Pharmacy Courses

FDA Inspection Checklist


FDA Inspection

The Food and Drug Administration (FDA) conducts inspections and assessments of FDA regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts.

FDA inspections cover following sectors -

  • vaccine and drug manufacturers
  • blood banks
  • food processing facilities
  • dairy farms
  • animal feed processors
  • compounding pharmacies
  • facilities that conduct studies in people (clinical trials)
  • laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product
  • foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States
  • imported regulated products at the border

Types of FDA Inspection

  1. pre-approval inspection after a company submits an application to FDA to market a new product
  2. routine inspection of a regulated facility
  3. “for-cause” inspection to investigate a specific problem that has come to FDA’s attention
  4. Compliance follow-up– if violations are found during an inspection, an FDA Form 483 will list the violations and the FDA will return to reinspect to confirm if corrective actions were taken to rectify the issues previously observed.

FDA Inspection Checklist

  • Inspection  scope and objective
  • Pre-determine the SMEs (Subject Matter Experts)
  • Assign co-ordinator
  • Assign Designated Individual
  • Ensure Ease of Records Access
  • Document Controls and Procedures
  • In-process Control
  • Finished Product Control
  • Deviation, OOS and OOT management
  • Ensure SOPs are up-to-date and follow properly 
  • Conduct and list out the Mock audit Observation and correct properly
  • Check and correct the previous audits observation
  • Review your quality manual policy

How to Manage an FDA Inspection?

  • Pharma companies should have made arrangements for a comfortable work area for the FDA inspector(s) for the duration of the inspection. The room must contain no confidential records, including clinical or research related. The inspector should be accompanied by the escort or designee at all times while in the presence of study related documents, samples, or other confidential information.
  • Follow the below suggestions during answering to FDA:
- Be concise; answer only the question that is asked.
- Always be clear with the answers to questions.
- Be positive and confident.
- Take corrective actions if possible, commit only to what you can deliver.
- DO NOT lie. DO NOT argue.
- DO NOT panic.
- DO NOT sign affidavits.
- DO NOT volunteer information. 
- DO NOT guess or speculate.

FDA Investigation vs Inspection

  • Investigation is less common, information-gathering (e.g. gathering information about a Consumer Complaint). Sometimes an investigation is required to determine if an inspection is applicable/needed.
  • Inspection is determining compliance with laws/regulations.

Related: Regulatory Inspection Management in Pharmaceutical Industry

FDA Inspection How Often Perform?

  • General GMP inspections are performed approximately every two years.
  • Pre-approval inspections are performed during filing of NDA or ANDA.
  • For cause inspections are performed for recall or complaints.

When the FDA conducts an inspection, the inspectors will:

  • inspect the facilities to determine a firm's compliance with applicable laws and regulations.
  • review the regulatory documents that are summitted during filing.

Read also:

Tags in: fda inspection frequency, fda inspection list, fda audit preparation, pai fda inspection, eir fda inspection, us-fda inspection checklist, fda inspection guide.

Previous Post Next Post