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At FDAInspections.com, we specialize in helping biologics manufacturers, developers, contract organizations (CMOs, CDMOs), and sponsors navigate the complex and high-stakes world of FDA biologics inspections and compliance requirements. Whether you are preparing for a Pre-License Inspection (PLI), a routine cGMP audit, or responding to a Warning Letter, our team provides expert guidance and practical strategies to protect your products, your patients, and your business.

Our mission: Ensure biologics companies meet stringent FDA and CGMP standards, pass inspections, and successfully launch and maintain market access.

Why FDA Inspections of Biologics Matter

Biologics are regulated under:

• 21 CFR Parts 600–680 – Biologics regulations

• 21 CFR Part 1271 – Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

• 21 CFR Part 210/211 – CGMP for Drugs and Biologics

• Public Health Service (PHS) Act

Failure to comply can result in:

• Form FDA 483 Observations

• Warning Letters

• Clinical hold orders

• License suspension or revocation

• Product seizures and injunctive actions

🔗 Learn About FDA Biologics Regulations (FDA.gov)

How FDAInspections.com Helps Biologics Companies

1. FDA Inspection Readiness Audits for Biologics

We conduct in-depth, risk-based audits modeled after FDA biologics inspection protocols.

• Pre-License and Pre-Approval Inspection readiness (PLI/PAI)

• cGMP and cGTP compliance audits

• Documentation, batch record, and deviation management reviews

• Facility walkthroughs, equipment qualification, and data integrity audits

Schedule a Biologics Compliance Audit

2. 483 Response and Warning Letter Assistance

If your facility receives an FDA Form 483 or Warning Letter, we provide urgent remediation support.

• Root cause analysis

• Corrective and Preventive Action (CAPA) development

• 483 response drafting and evidence packages

• Mock re-inspections and FDA communication strategies

Get Help With Your 483 Response

3. Pre-License and Pre-Approval Inspection (PLI/PAI) Preparation

Launching a new biologic product requires navigating rigorous FDA inspections.

• Biologics License Application (BLA) support

• Facility and quality system inspection readiness

• Validation program assessment (process, cleaning, analytical methods)

• Clinical manufacturing site preparation

Prepare for Your Biologics License Application Inspection

4. Risk Management, CAPA Systems, and Data Integrity Compliance

We help ensure your biologics operation meets FDA expectations for continuous improvement and data integrity.

• Robust CAPA system implementation

• Risk management aligned with ICH Q9 principles

• Electronic data and audit trail compliance (21 CFR Part 11)

Strengthen Your Biologics Compliance Systems

Common FDA Focus Areas During Biologics Inspections

• Master production and batch record accuracy

• Environmental monitoring and aseptic operations

• Validation of manufacturing and laboratory processes

• Control of critical raw materials and suppliers

• Complaint handling and adverse event reporting (AER)

• Lot release protocols and documentation

• Data integrity and electronic recordkeeping compliance

Types of Biologic Products We Support

At FDAInspections.com, we assist companies across the biologics sector, including:

Vaccines

• Viral vaccines

• Bacterial vaccines

• Combination vaccines

Support includes:

• Manufacturing process review and validation

• Aseptic operations and contamination control strategies

Blood and Blood Components

• Plasma products

• Red blood cells, platelets

• Plasma derivatives (e.g., clotting factors)

Support includes:

• cGMP compliance for blood collection and processing

• AER and adverse reaction reporting setup

Cellular and Gene Therapies

• CAR-T therapies

• Gene editing products

• Ex vivo gene therapy products

Support includes:

• cGTP and cGMP hybrid compliance support

• Validation and risk assessment of novel processes

Human Tissue Products (HCT/Ps)

• Stem cell therapies

• Amniotic tissue products

• Bone, skin, and reproductive tissues

Support includes:

• Registration and listing compliance under 21 CFR Part 1271

• Donor eligibility determination program setup

Allergenics and Biological Devices

• Allergen extracts

• Combination biological-device products

Support includes:

• Regulatory pathway navigation

• Inspection preparation for biologic-device integration facilities

Frequently Asked Questions About FDA Biologics Inspections

Q: How are biologics inspections different from pharmaceutical inspections?
A: Biologics inspections often involve additional review of clinical trial compliance, donor eligibility (for cell/tissue products), lot release processes, and aseptic control strategies, in addition to cGMP evaluations.

Q: What triggers an FDA biologics inspection?
A: Inspections can be routine surveillance, PLI/PAI for product approvals, for-cause investigations based on complaints, or biologics manufacturing changes.

Q: What is the biggest FDA enforcement risk for biologics companies?
A: Data integrity violations, sterility failures, lot release failures, and noncompliance with 21 CFR Parts 600–680 are the most common triggers for enforcement actions.

Q: Can FDAInspections.com help emerging or clinical-stage biologics companies?
A: Absolutely. We work with pre-market clinical stage, commercial launch, and post-market biologics manufacturers at every phase of regulatory engagement.