Terms of Service and Disclaimer

Effective Date: August 25, 2026
Last Updated: August 25, 2026

These Terms of Service and Disclaimer (“Terms”) govern access to and use of fdaapc.com and all websites, publications, downloads, communications, advisory materials, and preliminary services operated or provided by CIRG (“CIRG,” “Consultant,” “we,” “us,” or “our”).

These Terms apply to every current and future page, post, article, landing page, resource, download, media file, subdomain, renamed page, and replacement URL published through fdaapc.com. A page does not need to appear individually in these Terms to fall within their scope.

A separately executed consulting agreement, proposal, statement of work, or engagement letter may contain additional terms.

1. Acceptance of These Terms

By accessing fdaapc.com, requesting information, downloading materials, submitting an inquiry, or engaging our services, you acknowledge these Terms.

If you use our websites or services for an organization, you represent that you have authority to act for that organization. The organization also agrees to these Terms.

If you do not accept these Terms, discontinue using the websites, materials, and services.

2. Professional and Business Use

CIRG provides regulatory, quality, compliance, validation, remediation, and inspection-readiness consulting primarily to businesses and professionals operating in regulated industries.

Our services are not intended for personal, family, or household purposes. Nothing in these Terms eliminates any right that applicable law does not permit a party to waive.

3. Nature of Website Content and Advisory Materials

Website content, articles, diagrams, publications, downloads, training materials, and preliminary communications serve educational, informational, and advisory purposes.

They do not constitute:

• Legal advice or legal representation

• Medical or clinical advice

• Regulatory approval, clearance, or certification

• Product release authorization

• Government guidance or official policy

• A guarantee of compliance or inspection success

• A substitute for applicable laws, regulations, standards, or official government publications

Regulatory requirements, policies, compliance programs, and enforcement practices can change. Users should confirm current requirements through official government sources and obtain qualified legal advice when legal interpretation becomes necessary.

4. Consulting Services and Related Information

CIRG may provide mock inspections, compliance reviews, regulatory analysis, inspection assistance, remote readiness assessments, response support, remediation advice, training, documentation assessments, and ongoing FDA Consulting.

Additional information appears on the following pages:

• Mock FDA Inspection

• Drug CGMP Inspection Model

• FDA Classifications

• FDA Combination Product Inspection

• FDA Consulting

• FDA Form 483 Response

• FDA Inspection Assistance

• FDA QMSR Inspection Model

• FDA Warning Letter Response

• Former FDA Expertise

• Mock FDA Pre-Approval Inspection

• On-Demand FDA Consulting

• Remote FDA Inspection Readiness

• Services

• The Executive Case for a Mock FDA Inspection

These linked pages describe possible services and provide general educational information. They do not create warranties, guarantees, contractual deliverables, or an obligation to provide any particular service.

Future pages published through fdaapc.com will also remain subject to these Terms. Their publication will not independently create a consulting engagement, warranty, guarantee, or expanded scope of services.

Only a written agreement signed or otherwise expressly accepted by CIRG and the client establishes an engagement’s scope, deliverables, responsibilities, schedule, and fees.

5. No Government Affiliation, Endorsement, or Authority

CIRG is a private, independent consulting firm. CIRG is not the U.S. Food and Drug Administration (“FDA”), part of FDA, or any other government authority.

CIRG does not act for, represent, speak for, or exercise authority on behalf of FDA or another government body.

References to FDA, the Agency, regulations, compliance programs, inspections, forms, policies, guidance documents, or government personnel serve identification, educational, informational, and advisory purposes.

Such references do not imply government:

• Affiliation

• Authorization

• Approval

• Certification

• Sponsorship

• Partnership

• Representation

• Endorsement

Nothing on fdaapc.com or in a CIRG service should be interpreted as an official government communication.

The domain name fdaapc.com identifies the subject of CIRG’s independent regulatory consulting services. It does not indicate government ownership, operation, authorization, affiliation, or endorsement.

6. Former Government Experience

Descriptions such as “former FDA investigator,” “former FDA compliance officer,” “former FDA reviewer,” “former FDA expert,” “investigator perspective,” “FDA perspective,” or similar language describe prior professional experience.

Former government employment does not provide continuing government authority, official status, endorsement, special access, influence, or permission to speak for the government.

Opinions based on former government experience represent independent professional judgment. They do not constitute current Agency policy, official interpretations, legal advice, or predictions about how current personnel will handle a matter.

CIRG does not promise preferential treatment or influence over regulatory decisions. Its services do not include improper influence, access to nonpublic government information, or disclosure of confidential government information.

7. Mock Inspections and Remote Assessments Are Not Official Activities

A CIRG mock FDA inspection, readiness assessment, remote assessment, gap assessment, or simulation is an independent consulting activity.

It is not an official Agency inspection, investigation, Remote Regulatory Assessment, certification, approval, or enforcement proceeding.

CIRG personnel cannot exercise government inspection authority. They cannot compel records, collect official samples, administer official affidavits, issue government correspondence, classify an inspection, or make determinations for the Agency.

Simulation of document requests, interviews, facility walkthroughs, sampling methods, remote technology, or inspection conditions does not transform an assessment into an official government activity.

8. Inspection Assistance During an Official Inspection

CIRG may provide independent advisory support before or during an official inspection when authorized through a written engagement.

CIRG does not control an official inspection, direct FDA personnel, interfere with lawful inspection activities, or determine the inspection’s scope.

Unless expressly authorized in writing, CIRG does not speak for the client or communicate directly with investigators on the client’s behalf.

The client remains responsible for:

• Cooperation with lawful Agency requests

• Accuracy of statements and records

• Selection of documents presented

• Protection of legally privileged information

• Communications with investigators

• Decisions concerning corrections or commitments

• Escalation to legal counsel when appropriate

CIRG will not advise a client to conceal, alter, destroy, fabricate, delay, or misrepresent information.

Inspection assistance cannot guarantee that investigators will accept an explanation, limit inspection coverage, avoid observations, or reach a favorable classification.

9. No Official Determinations or Regulatory Guarantees

CIRG cannot issue or provide:

• Government approvals, authorizations, or clearances

• Regulatory certifications

• Official product or device classifications

• Official inspection classifications

• Form FDA 483 observations

• Warning Letters or close-out letters

• Import Alert decisions

• Product approvals or market authorizations

• Binding interpretations of government policy

• Protection from inspection or enforcement action

CIRG cannot bind the Agency, control government personnel, prevent enforcement, or guarantee a regulatory outcome.

Every mock inspection, assessment, report, training program, opinion, and recommendation represents independent consulting work. No CIRG service or material has received FDA approval, adoption, certification, sponsorship, authorization, or endorsement unless CIRG identifies specific written authorization.

10. Product Classification and Regulatory Pathway Disclaimer

Information concerning product classification, intended use, premarket pathways, 510(k), PMA, NDA, ANDA, BLA, combination products, or other submissions serves general educational and advisory purposes.

Product classification and regulatory pathway decisions depend on the product, intended use, claims, technology, constituent parts, risk, regulatory history, and current Agency requirements.

A CIRG assessment or opinion does not constitute an official classification or binding FDA determination.

Clients remain responsible for confirming the applicable pathway and obtaining legal or official regulatory clarification when necessary.

11. Pre-Approval Inspection Disclaimer

A mock Pre-Approval Inspection is an independent readiness exercise. It is not an official FDA PAI and does not indicate that an application will receive approval.

CIRG cannot control application review, inspection scheduling, inspection coverage, information requests, approval decisions, or post-inspection regulatory action.

Clients remain responsible for:

• Application accuracy and completeness

• Data integrity

• Manufacturing readiness

• Process and method validation

• Facility and equipment qualification

• Batch and product records

• Commitments made within regulatory submissions

• Responses to Agency questions

Successful completion of a mock PAI does not guarantee application approval or a favorable official inspection outcome.

12. Form FDA 483 and Warning Letter Response Disclaimer

CIRG may provide advisory support for responses to Form FDA 483 observations, Warning Letters, inspection correspondence, or related compliance matters.

Such assistance does not constitute legal representation or guarantee that the Agency will accept the response, close the matter, change a classification, or decline further action.

The client remains responsible for:

• Meeting applicable response deadlines

• Confirming factual accuracy

• Approving every commitment

• Implementing corrective and preventive actions

• Providing complete supporting evidence

• Verifying corrective-action effectiveness

• Obtaining legal advice when appropriate

CIRG cannot issue, withdraw, revise, close, or otherwise control official Agency correspondence.

13. Government Names, Marks, Seals, and Materials

Government names and regulatory references identify relevant authorities, programs, forms, regulations, or publications.

CIRG does not claim ownership of government names, marks, seals, logos, or official materials. CIRG will not use a government seal or logo to suggest official status, sponsorship, or endorsement.

References to FDA in ordinary text identify the relevant regulatory authority. Such references do not make CIRG part of the Agency.

14. Regulatory Representation

CIRG does not serve as legal counsel or provide legal representation.

CIRG does not communicate with government authorities on a client’s behalf, submit regulatory materials, or act as a regulatory representative unless a written engagement expressly authorizes that work.

Even when CIRG assists with regulatory communications or submissions, the client remains responsible for reviewing and authorizing all representations made on its behalf.

Unless expressly agreed in writing, CIRG does not act as a:

• Manufacturer

• Specification developer

• Regulatory sponsor

• Marketing authorization holder

• U.S. Agent

• Authorized representative

• Importer

• Distributor

• Product owner

• Responsible person

• Legal representative

15. Client Responsibility

The client retains full responsibility for its products, facilities, operations, quality systems, submissions, communications, and regulatory compliance.

The client remains responsible for:

• Compliance with applicable laws, regulations, and standards

• Product design, manufacture, testing, validation, and release

• Labeling, promotion, storage, distribution, and postmarket activities

• Accuracy and completeness of information supplied to CIRG

• Regulatory submissions and representations

• Communications with regulatory authorities

• Decisions concerning the implementation of CIRG recommendations

• Selection and supervision of employees, contractors, laboratories, and suppliers

• Reporting deadlines and regulatory commitments

• Final business, quality, technical, legal, and compliance decisions

CIRG provides recommendations based on the information available during the engagement. The client must evaluate those recommendations within its complete technical, operational, clinical, and legal circumstances.

16. Separate Consulting Agreements

A signed consulting agreement, engagement letter, proposal, or statement of work may establish additional terms for paid services.

If a separate agreement conflicts with these Terms, the separate agreement controls the specific engagement. These Terms continue to govern website use and materials outside that engagement.

Marketing pages, discussions, estimates, or preliminary proposals do not expand an executed scope of work unless the parties agree in writing.

17. No Warranty or Guaranteed Outcome

Website content and publicly available materials are provided “as is” and “as available,” to the fullest extent permitted by law.

CIRG does not warrant that website content will always remain accurate, complete, current, uninterrupted, secure, or error-free.

Unless an executed agreement expressly states otherwise, CIRG makes no guarantee concerning:

• Inspection results or classifications

• Regulatory approval or clearance

• Acceptance of a submission or response

• Avoidance of Form FDA 483 observations

• Avoidance of Warning Letters or enforcement action

• Successful remediation

• Certification or market authorization

• Commercial performance

• Continued market access

• A particular compliance determination

Professional services can reduce uncertainty and identify potential weaknesses. They cannot eliminate regulatory, technical, operational, or commercial risk.

18. Acceptable Website Use

Users may access fdaapc.com for lawful informational and professional purposes.

Users must not:

• Attempt unauthorized access to a website, account, server, or system

• Introduce malicious code or interfere with website operation

• Misrepresent identity, authority, affiliation, or employment

• Scrape, copy, or systematically extract content without permission

• Use CIRG materials to mislead another party

• Remove copyright, attribution, or proprietary notices

• Use the websites or materials for unlawful or fraudulent purposes

• Imply that CIRG endorses a third party without written permission

• Present CIRG materials as official government materials

CIRG may restrict or terminate access when it reasonably believes misuse, security threats, or violations have occurred.

19. Intellectual Property

Unless otherwise stated, CIRG owns or licenses its original website content, publications, diagrams, reports, assessments, training materials, methods, and advisory materials.

CIRG grants users a limited, revocable, nonexclusive, nontransferable license to view website content for lawful internal business or informational use.

Users may not reproduce, distribute, sell, publish, modify, create derivative works from, or commercially exploit CIRG materials without prior written permission.

Government publications, third-party standards, trademarks, and linked materials remain subject to their applicable ownership, access, and usage rules.

20. Submissions, Inquiries, and Confidential Information

Submitting a website inquiry does not create a consulting relationship, fiduciary relationship, or confidentiality obligation.

Do not submit trade secrets, patient information, protected health information, security credentials, controlled technical information, or other sensitive material through a general website form.

CIRG may use information submitted through a form to evaluate and respond to the inquiry. The Privacy Policy describes how CIRG handles personal information.

Confidentiality obligations arise only through an applicable written agreement, nondisclosure agreement, or other express written commitment.

21. Independent Relationship

CIRG acts as an independent consultant.

Nothing in these Terms creates a partnership, joint venture, employment, franchise, fiduciary, government agency, or other representative relationship.

Neither party may bind the other unless a written agreement expressly grants that authority.

22. Third-Party and Government Links

Fdaapc.com may link to government websites, standards organizations, publications, service providers, or other third-party resources.

Links serve convenience and reference purposes. A link does not imply that CIRG controls, approves, endorses, or accepts responsibility for the linked source.

Third-party websites maintain their own terms, privacy practices, content, and availability. Users should review those terms independently.

23. Limitation of Liability

To the fullest extent permitted by applicable law, CIRG will not be liable for indirect, incidental, special, consequential, exemplary, or punitive damages arising from website use, advisory materials, or services.

This limitation includes alleged losses involving:

• Revenue, profit, contracts, or business opportunities

• Data, goodwill, reputation, or market value

• Business interruption or production delays

• Regulatory submissions or market authorization

• Warning Letters, recalls, seizures, injunctions, or Import Alerts

• Product holds, withdrawals, or enforcement proceedings

• Application review or approval delays

• Third-party claims involving a client’s products

• Decisions made from incomplete or inaccurate client information

For a paid engagement without a separate liability provision, CIRG’s total aggregate liability will not exceed the professional fees actually paid for the specific service giving rise to the claim.

For website content or materials provided without charge, aggregate liability will not exceed the amount paid, if any, to access the specific material.

Nothing in these Terms excludes or limits liability that applicable law does not permit the parties to exclude, including responsibility for fraud, willful misconduct, or violations of law where such responsibility cannot legally be waived.

24. Indemnification

To the fullest extent permitted by law, the client agrees to defend, indemnify, and hold harmless CIRG and its officers, employees, consultants, and affiliates from third-party claims arising from:

• The client’s products, services, facilities, or operations

• Inaccurate or incomplete information supplied by the client

• The client’s regulatory submissions or representations

• The client’s implementation or rejection of recommendations

• The client’s classification, validation, testing, or product-release decisions

• The client’s violation of law or these Terms

• The client’s misuse of CIRG materials

• Claims made by the client’s customers, distributors, contractors, laboratories, or suppliers

This obligation does not apply to the extent a final determination attributes the claim to conduct for which applicable law prohibits indemnification.

25. Force Majeure

CIRG will not be liable for delay or failure caused by circumstances beyond its reasonable control.

Such circumstances may include government action, regulatory changes, natural disasters, public health emergencies, internet failures, cyber incidents, utility interruptions, labor disruptions, transportation failures, civil unrest, or similar events.

26. Suspension and Termination

CIRG may suspend or terminate website access when a user violates these Terms, threatens website security, infringes intellectual property, or engages in unlawful conduct.

Termination does not affect rights or obligations that arose before termination.

Provisions concerning intellectual property, confidentiality, disclaimers, liability, indemnification, dispute resolution, and governing law survive termination.

27. Dispute Resolution and Arbitration

Before initiating formal proceedings, a party must provide written notice describing the dispute and allow 30 days for good-faith resolution discussions.

Except for disputes eligible for small-claims court or requests for temporary injunctive relief, disputes arising from these Terms will be resolved through binding arbitration before one neutral arbitrator in California.

Unless the parties agree otherwise, JAMS will administer the arbitration under its applicable rules. The Federal Arbitration Act governs the arbitration provision where applicable.

To the fullest extent permitted by law:

• Claims must proceed individually

• The parties waive participation in class or collective actions

• The parties waive trial by jury for disputes heard in court

Nothing in this section removes rights or remedies that applicable law does not permit a party to waive.

28. Governing Law and International Users

California law governs these Terms without regard to conflict-of-law principles.

For disputes not subject to arbitration, the parties consent to the jurisdiction of courts located in California, subject to any non-waivable jurisdictional rights.

Users outside the United States remain responsible for compliance with applicable local laws.

If mandatory consumer law applies, the choice of California law and arbitration provisions will not deprive a consumer of protections that cannot legally be waived in the consumer’s place of residence.

29. Future Pages and Services

These Terms automatically apply to future CIRG content and services published through fdaapc.com.

Coverage includes:

• New or renamed service pages

• Articles and educational resources

• Landing pages and campaign pages

• Future inspection models and regulatory topics

• Videos, diagrams, webinars, and downloads

• Subdomains and mobile versions

• Replacement URLs and redirected pages

• New mock-inspection, response, remediation, training, and consulting services

Adding a future page or resource does not require CIRG to republish these Terms. However, CIRG may update the Terms when new services or legal requirements justify additional provisions.

A future page does not create a contractual deliverable or guarantee unless an executed engagement agreement expressly incorporates it.

30. Changes to These Terms

CIRG may update these Terms to reflect changes in services, laws, business practices, regulatory developments, or website functionality.

The revised version will display a new “Last Updated” date. Material changes will apply prospectively unless applicable law permits otherwise.

Changes to these website Terms do not modify an executed consulting agreement unless the parties amend that agreement according to its terms.

31. Entire Agreement, Severability, and Waiver

These Terms, together with the Privacy Policy and any applicable written engagement agreement, constitute the relevant agreement concerning website use and services within their respective scopes.

If a provision becomes invalid or unenforceable, the remaining provisions continue in effect. An unenforceable provision will be interpreted as closely as legally permitted to its intended purpose.

A failure to enforce a provision does not waive the right to enforce it later.

32. Contact

Questions about these Terms, website content, or CIRG services may be submitted through the CIRG contact page.

Formal notices concerning a paid engagement should also follow the notice requirements in the applicable consulting agreement.