Pharmaceutical FDA Inspections and Compliance Support
Navigate FDA Pharmaceutical Inspections With Confidence and Expertise
At FDAInspections.com, we help long-term, established and start-up pharmaceutical manufacturers, contract manufacturers (CMOs), and packagers prepare for and succeed during FDA inspections. Whether you’re facing a Pre-Approval Inspection (PAI), a routine cGMP inspection, or a for-cause audit, our team of experts provides the strategic guidance and hands-on support you need to stay compliant and inspection-ready.
Our mission: Empower pharmaceutical companies to pass FDA inspections, resolve FDA-483s and Warning Letters, and build defensible quality systems that withstand regulatory scrutiny.
Types of Pharmaceutical Products We Support
At FDAInspections.com, we help pharmaceutical companies, contract manufacturers (CMOs), packagers, and distributors across a broad range of drug product types, including:
Prescription Drug Products (Rx)
Tablets, capsules, oral suspensions
Injectable drugs (vials, prefilled syringes, IV solutions)
Topical creams, ointments, gels
Support includes:
cGMP readiness audits for 21 CFR Part 210/211 compliance
Batch record review and deviation management
483 response and Warning Letter remediation for drug manufacturing issues
Over-the-Counter (OTC) Drug Products
Analgesics (pain relievers), cough and cold products
Antiseptics, first aid creams, sunscreen products
Anti-dandruff shampoos, fluoride toothpaste
Support includes:
Label compliance under FDA Monographs and OTC labeling rules
cGMP compliance checks for OTC manufacturing sites
Recall readiness and complaint handling system reviews
Sterile Products
Injectable solutions
Ophthalmic (eye) products
Inhalation therapies
Support includes:
Aseptic processing validation audits
Environmental monitoring program evaluations
Sterility assurance and cleanroom operations readiness
Biologic Products (Traditional Biologics)
Vaccines, allergenics, blood products
Cell-based therapies (traditional CBER products)
Support includes:
Biologics License Application (BLA) inspection preparation
Cross-functional regulatory pathway support (21 CFR Part 600–680)
Facility and quality system inspection readiness
Active Pharmaceutical Ingredients (APIs) and Excipients
Raw material manufacturers and distributors
Contract API manufacturers
Support includes:
API cGMP inspections (ICH Q7 compliance)
Supplier qualification programs
Data integrity and laboratory control audits
Why FDA Pharmaceutical Inspections Matter
Pharmaceutical inspections are governed by strict FDA regulations under:
21 CFR Part 210 – Current Good Manufacturing Practice (cGMP) for Manufacturing, Processing, Packing, or Holding of Drugs
21 CFR Part 211 – cGMP for Finished Pharmaceuticals
21 CFR Part 600 – Biological Products: General
Failure to comply can result in:
Form FDA 483 Observations
Warning Letters
Import Alerts
Consent Decrees
Product seizures or recalls
Preparation, documentation, and culture of quality are non-negotiable in today’s regulatory environment.
🔗 Learn about cGMP Regulations for Pharmaceuticals (FDA.gov)
How FDA Inspections .com Helps Pharmaceutical Companies
1. FDA Inspection Readiness Audits
We perform in-depth mock inspections modeled after FDA procedures to uncover vulnerabilities before real inspectors do.
Comprehensive cGMP system audits
SOP, batch record, and deviation review
Facility walkthroughs and data integrity checks
Interview preparation for QA, QC, Production, and Regulatory Affairs teams
Schedule an FDA Readiness Audit
2. FDA-483 Response and Warning Letter Remediation
If you’ve received a FDA_483 or Warning Letter, FDAInspections.com provides urgent and effective remediation support.
Root cause analysis
Corrective and Preventive Action (CAPA) plan development
Professional FDA-483 responses that meet FDA expectations
Mock re-inspections to ensure readiness for FDA follow-up
Get Help With Your 483 Response
3. Pre-Approval Inspection (PAI) Preparation
Launching a new drug product? We help you prepare for your critical Pre-Approval Inspection.
NDA, ANDA, or BLA inspection readiness
Validation program reviews (process, cleaning, analytical)
Site Master File (SMF) and quality system readiness evaluations
Prepare for Your PAI Inspection
4. Data Integrity and Electronic Records Compliance
We assess and strengthen compliance with 21 CFR Part 11 for electronic records and data integrity.
Data lifecycle reviews
Audit trail evaluations
Risk-based gap assessments and remediation planning
Learn More About Data Integrity Support
Common Areas of FDA Pharmaceutical Inspection Focus
Batch production and control records
Laboratory controls and Out-of-Specification (OOS) procedures
Change control processes
Cleaning validation
Equipment qualification (IQ, OQ, PQ)
Annual Product Reviews (APR)
Supplier qualification and management
Personnel training and qualification
Frequently Asked Questions About Pharmaceutical FDA Inspections
Q: What triggers an FDA pharmaceutical inspection?
A: Inspections may be routine (biennial surveillance), for a new product approval (PAI), or for-cause based on complaints, recalls, or previous compliance issues.
Q: What is the difference between a PAI and a surveillance inspection?
A: A Pre-Approval Inspection (PAI) evaluates readiness to market a new product under an NDA or ANDA, while surveillance inspections evaluate ongoing cGMP compliance at established facilities.
Q: How long does it take to prepare for an FDA inspection?
A: Ideally, inspection readiness is an ongoing state. However, a focused preparation project typically takes 4–12 weeks depending on gaps identified.
Q: Can FDAInspections.com help even after a 483 or Warning Letter?
A: Absolutely. We specialize in rapid response, CAPA development, and helping companies successfully navigate follow-up inspections and demonstrate sustainable corrections.
Q: Do you offer remote (virtual) inspection readiness support?
A: Yes. We offer both remote document reviews, virtual mock inspections, and in-person site assessments depending on client needs.
FDAInspections.com — Your Trusted Partner for Pharmaceutical FDA Compliance and Inspection Success.