How to prepare for a CP 7356.002 Drug Manufacturing Inspection?

Preparation centers on the Six-System Model. Key steps include mobilizing a Front/Back Room team, conducting forensic data integrity audits of CDS/LIMS audit trails, and ensuring CAPAs and OOS investigations have scientifically sound root causes.

What are the 2026 FDA requirements for 21 CFR Part 4 combination products?

Manufacturers should align their quality system approach with QMSR expectations. For combination products, this typically includes integrating risk-based controls and design/production controls appropriate to the device constituent while maintaining drug quality system requirements.

How does ICH Q7 apply to pharmaceutical APIs?

ICH Q7 provides GMP guidance for APIs, including quality management, materials management, production, packaging, labeling, storage, and distribution controls. Inspection readiness typically focuses on traceability, change control, deviations, investigations, and impurity control strategy.

What is the difference between an Abbreviated and Full FDA pharmaceutical inspection?

An Abbreviated inspection is a more limited scope used in some routine surveillance contexts, while a Full inspection is broader in scope. The actual scope is determined by FDA based on risk and compliance history.

Why should you select us for your mock FDA inspection?

We run high-fidelity mock inspections led by former FDA investigators and focus on actionable findings, data integrity, and practical CAPA execution so you can host FDA confidently.

FDA Inspection Assistance by an ex-FDA Investigator

FDA Inspection Assistance When It Matters

CIRG provides FDA inspection assistance for medical device, pharmaceutical, food, and dietary supplement companies. During an active inspection, our former FDA experts advise leadership, coordinate document requests, prepare subject experts, and assess emerging concerns. CIRG’s FDA consulting gives your team an experienced regulatory perspective while management retains control of all decisions and responses.

Support may occur onsite or remotely, depending on timing and availability. A mock FDA inspection gives CIRG valuable knowledge of your systems, facility, and risk profile. During the inspection, we help your team communicate accurately, remain organized, and respond with appropriate evidence. Our role supports your operation without disrupting the FDA investigator’s work.

Contact CIRG as Soon as FDA Engages

FDA conducts both announced and unannounced inspections, depending on the program and circumstances. Contact CIRG immediately after receiving notice or when an investigator arrives. Early communication allows us to assess availability, inspection scope, operational needs, and appropriate support.

When possible, CIRG gives scheduling priority to facilities that previously completed a mock FDA inspection. Prior work helps us understand your systems and prepare quickly. When FDA provides advance notice, CIRG can establish inspection roles, document workflows, escalation pathways, and daily briefing plans.

Focused FDA consulting also prepares executives and subject experts for likely questions. If onsite support remains unavailable, CIRG can provide remote guidance whenever circumstances permit.

Build Readiness Before FDA Arrives

Strong inspection performance starts long before FDA arrives. Do not rely on rushed or cosmetic corrections immediately before the inspection. Identify gaps early, correct root causes, document actions, and verify that improvements remain effective.

CIRG’s FDA consulting helps management prioritize risks and build sustainable inspection readiness. A mock FDA inspection challenges procedures, records, facility practices, document retrieval, and employee responses under realistic conditions. Findings give your team time to strengthen weak controls before they attract FDA scrutiny.

If a safe correction becomes appropriate during an inspection, implement it carefully and preserve supporting evidence. Afterward, evaluate the broader impact and prevent recurrence. Continuous readiness supports compliance more effectively than last-minute preparation.

Contact CIRG for FDA Inspection Assistance

Technical Support for FDA Inspections

CIRG helps quality and leadership teams manage the technical demands of an FDA inspection. When the FDA gives advance notice, our consultants can arrive two or three days early, subject to availability. This time allows us to review roles, document control, escalation paths, facility access, and likely inspection focus areas. During the inspection, CIRG’s FDA consulting provides practical advice without interfering with the investigator or replacing management’s decisions.

Our former FDA investigators help subject experts prepare accurate, concise, and evidence-supported responses. They review key quality system documents, examine potential vulnerabilities, and support daily debriefs. A mock FDA inspection can test these processes before the FDA arrives. The exercise identifies gaps in procedures, records, training, investigations, and daily execution.

CIRG does not promise a specific inspection outcome. Instead, we help your team make informed decisions, respond professionally, and address risks through documented corrective action. This support gives management an experienced perspective when questions or unexpected issues emerge.

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Former FDA Consumer Safety Officer Support

Medical device, pharmaceutical, biotechnology, and dietary supplement manufacturers face different FDA requirements. CIRG helps your team understand applicable obligations, assess current practices, and prepare for inspection. Our former FDA Consumer Safety Officer brings firsthand experience with inspection procedures, evidence review, and regulatory observations.

CIRG’s FDA consulting combines that perspective with practical quality system support. A mock FDA inspection tests your facility, records, procedures, and personnel under realistic conditions. During an active inspection, CIRG can advise management, support document coordination, and help subject experts prepare accurate responses.

We cannot guarantee an inspection outcome or certify compliance. Instead, we identify risks, strengthen readiness, and help your organization make informed decisions.

Why Manufacturers Choose CIRG

CIRG works directly with quality and leadership teams without unnecessary consulting layers. Each FDA consulting engagement reflects your products, facility, inspection history, and operational risks. A mock FDA inspection follows realistic evidence trails through documents, interviews, and facility practices.

You receive direct former FDA experience, product-specific preparation, and practical recommendations. Support may occur onsite or remotely, depending on timing and availability. Clear findings help management prioritize corrective actions before an investigator identifies the same concerns.

Contact CIRG before your next FDA inspection to discuss readiness or active inspection support.

FDA Inspection Assistance From a Former FDA District CSO

CIRG helps employees understand what to expect before and during an FDA inspection. Our former FDA District Consumer Safety Officer brings firsthand experience with investigator procedures and document requests. That experience also covers facility walkthroughs, employee interviews, and inspection observations. CIRG’s FDA consulting turns this knowledge into practical training for leadership, quality teams, and subject experts.

A mock FDA inspection allows employees to rehearse their roles under realistic conditions. Participants practice retrieving records, answering questions accurately, escalating concerns, and maintaining clear communication. Teams with limited inspection experience gain structure and confidence without relying on scripted responses.

Early preparation creates more time to identify gaps and implement sustainable corrections. Contact CIRG promptly to plan employee training, inspection readiness, or active FDA inspection assistance.