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 Consulting Services for Inspection Readiness

Former FDA Expertise Supporting Regulatory Readiness

Are you preparing for an FDA inspection or concerned about your organization’s inspection readiness? CIRG FDA Consulting provides strategic FDA consulting services built on direct FDA experience. Our former FDA investigators and compliance professionals help medical device, pharmaceutical, and combination product manufacturers understand regulatory expectations, identify compliance risks, and strengthen their quality systems before the FDA arrives.

Our services include mock FDA inspection, FDA inspection assistance, Form FDA 483 response support, regulatory remediation, quality system assessments, employee training, and supplier or vendor quality audits. Unlike large consulting organizations that rely on broad teams, CIRG provides focused support from experienced professionals who understand how the FDA evaluates evidence, systems, records, and management decisions.

Our objective is not to promise compliance or guarantee inspection outcomes. Instead, we help organizations identify weaknesses, prioritize corrective actions, and prepare for the level of scrutiny expected during an FDA inspection.

Specialized FDA Regulatory Capabilities

CIRG FDA Consulting supports manufacturers across multiple FDA-regulated industries and inspection programs. Our experience includes:

Remote Regulatory Assessment (RRA)

The FDA may use remote assessment approaches to evaluate firms, request documents, conduct interviews, and review compliance information without a traditional onsite inspection. CIRG helps organizations prepare for these interactions by evaluating document readiness, response processes, communication methods, and evidence management.

Drug CGMP Inspections Under CP 7356.002

Drug manufacturers must maintain systems that demonstrate control over production, quality, laboratory operations, materials, facilities, and documentation. CIRG provides FDA consulting based on the FDA six-system inspection model, including Quality System, CAPA, investigations, validation, laboratory controls, data reliability, and management oversight.

Medical Device QMSR Inspections Under CP 7382.850

With the implementation of the Quality Management System Regulation (QMSR), medical device manufacturers must understand how the FDA evaluates compliance under the updated inspection framework. CIRG helps organizations assess quality systems, design controls, CAPA effectiveness, complaint handling, supplier controls, and risk management.

Combination Product Compliance Under 21 CFR Part 4

Combination products require manufacturers to manage requirements that may involve both drug and device regulations. CIRG helps organizations understand applicable CGMP expectations, quality system interactions, and regulatory responsibilities for combination product operations.

ISO 13485 and Quality System Assessment

Many global medical device manufacturers operate under ISO 13485-based systems. CIRG evaluates whether quality systems are effectively implemented and aligned with FDA expectations, including process control, corrective action, risk management, and management responsibility.

Sterilization Validation and Aseptic Processing

CIRG provides technical regulatory support for sterilization processes, including EO, radiation, and moist heat sterilization validation. We also support aseptic process evaluations, including media fill assessments, contamination control strategy review, and inspection readiness.

Mock FDA Inspection and Inspection Readiness Support

A mock FDA inspection provides an opportunity to evaluate your organization before FDA evaluates you. CIRG uses former FDA inspection experience to assess whether your systems, documentation, employees, and management decisions can withstand regulatory scrutiny.

A realistic mock FDA inspection goes beyond reviewing procedures. It examines how your organization responds to questions, retrieves records, explains decisions, investigates problems, and demonstrates control over quality systems.

FDA inspections focus on evidence. They evaluate whether your processes operate as intended and whether management maintains effective oversight. CIRG helps organizations identify weaknesses before they become Form FDA 483 observations, regulatory concerns, or business disruptions.

Routine and For-Cause FDA Inspection Support

Whether preparing for a planned FDA inspection or responding to regulatory concerns, CIRG provides practical support based on real inspection experience. Our team assists organizations with inspection preparation, investigator interactions, document strategy, response development, and post-inspection remediation.

A mock FDA inspection can help organizations identify vulnerabilities before the FDA identifies them. However, the objective is not to create artificial findings or complete another checklist. The objective is to understand how the FDA may view your systems and whether your responses can withstand regulatory scrutiny.

Why Choose CIRG FDA Consulting

CIRG combines former FDA experience with practical industry understanding. Our team understands how FDA investigators evaluate evidence, how compliance concerns develop during inspections, and how organizations can strengthen their systems before regulatory pressure increases.

When you need FDA consulting support, choose a partner who understands both sides of the inspection process: what the FDA looks for and what companies must do to prepare.

Contact CIRG FDA Consulting today to discuss your inspection readiness needs.

Why Choose CIRG FDA Consulting Services?

CIRG FDA Consulting brings a unique perspective that combines former FDA inspection experience with real-world industry consulting. Our focus is not simply reviewing procedures or completing another checklist. We evaluate your systems the way FDA investigators evaluate them: through evidence, records, interviews, decision-making, and overall state of control.

Our mock FDA inspection services are supported by decades of experience evaluating pharmaceutical, medical device, and combination product operations. We have reviewed critical areas including aseptic processing, media fills, microbiological testing, laboratory controls, sterilization, environmental monitoring, cleaning validation, process validation, computerized systems, design controls, supplier controls, storage, and distribution.

The difference is perspective. We understand what companies see internally and what FDA sees externally. This allows us to challenge assumptions, identify overlooked risks, and provide practical recommendations based on inspection experience.

Experience Across Complex FDA-Regulated Operations

FDA inspections often examine how multiple systems connect. A weakness in one area may reveal broader issues involving quality oversight, validation, data integrity, manufacturing controls, or management responsibility.

CIRG has experience evaluating complex operations and reviewing documentation, including batch records, investigations, CAPA, validation packages, laboratory records, and quality system processes. Our approach focuses on whether your systems can withstand regulatory scrutiny, not whether documents simply appear complete.

A mock FDA inspection provides an opportunity to identify weaknesses before FDA identifies them. We help organizations understand which issues require immediate attention, which require additional evaluation, and how management can prioritize corrective actions.

Protecting Confidential Information While Providing Honest Feedback

Confidentiality is essential when conducting an independent assessment. CIRG protects client information and does not disclose proprietary details regarding products, processes, or quality systems.

At the conclusion of a mock FDA inspection, we discuss observations directly with management. We explain significant concerns, potential regulatory risks, and areas requiring improvement. Findings are discussed in the context of FDA inspection expectations, including whether similar conditions could contribute to Form FDA 483 observations.

Organizations may also request additional support after the assessment, including CAPA review, remediation strategy, and follow-up consultation. Remote support through email and telephone can provide continued guidance while reducing unnecessary travel costs.

CIRG FDA Consulting provides more than an audit. We provide an experienced regulatory perspective designed to help organizations prepare before FDA arrives.