5 Tips to Help You Prepare for an FDA Inspection

Regulatory authorities such as the FDA have gotten more stringent with their acceptance criteria, especially when it comes to food and drug or medical device companies. You will not always be informed about an FDA inspection in advance, so you need to be fully prepared at all times if you want to avoid Form 483 warning letters and citations!

Here are 5 tips that will help you be prepared when the FDA comes knocking:

  1. Review Quality Procedures and Practices – The FDA inspector or officer will review your quality system, so familiarize yourself with applicable regulations, guidance documents and manuals. It isn’t enough to draft procedures that comply with FDA approval requirements, though. Ensure that procedures align with the company’s manufacturing process and practices, since both will be reviewed and audited during the inspection.Also review past Form 483 warning letters and citations, non-conformation reports, batch reports, clinical trial and product performance reports, risk assessments, training records and operating procedures. Compliance to FDA 21 CFR Part 820 is required for medical device companies seeking FDA approval in the U.S., so make sure you have everything needed for demonstrating regulatory compliance.
  2. Perform Internal Quality Audits – An internal auditing program is ideal for ensuring that individual processes and your entire quality system meet FDA process validation and compliance requirements. Internal quality audits help you identify possible compliance problems and areas of concern, so you can adjust procedures and processes as required.Be tougher on yourself than the FDA would be. Make internal audits more comprehensive than an FDA inspection, especially for newly established processes. Follow the FDA guidance document on QSIT (Quality System Inspection Technique, a new process followed during inspections), i.e. FDA Guide to Inspections of Quality Systems.
  3. Don’t Rely on ISO Certification Alone – Pursuing and obtaining ISO 13485 certification is one of the main goals for companies manufacturing medical devices. Before getting certified, there are usually one or more audits conducted for compliance to the ISO standard, which can provide the impression of a good quality system.However, this is irrelevant in terms of FDA inspections, since ISO 13485 is related to European Medical Device Directives instead of FDA QSRs (Quality System Regulations). Of course, it’s possible for a single system to meet the requirements for both FDA 21 CFR Part 820 and ISO 13485, so you should take both regulations into account at the design stage.
  4. Ensure Your Team is Fully Prepared – FDA inspections are stressful, even when you’re prepared for them and have received advance warning. Look into training courses for FDA process validation, quality assurance and industry best practices. Use mock inspections to make sure everyone knows what to expect and how to handle it.Clearly define roles and responsibilities for team members or employees who will be involved in the inspection, and coach them on answering questions directly and responding specifically to what is asked. If you know other pharmaceutical manufacturers who’ve been audited, ask them to assess your preparations. Remember, preparation is a continuous process!
  5. Don’t Panic before Pending Inspections – A little panic is normal when you’re notified of an inspection, but here’s how to keep it under control:
    • Inform everyone about the pending inspection, but continue with routine production and regular business practices instead of changing them before the inspector arrives.
    • Designate an area for interviews, data collection and evaluation. Also assign a specific team member to accompany the inspector/officer at all times during their tour of the premises.
    • When the inspector points out issues that need correction, avoid trying to fix them during the inspection. If you don’t understand their comments, ask for clarification instead of trying to guess at what they mean.
    • If you don’t agree with observations, avoid being argumentative or defensive. You have to follow FDA rules whether you agree with them or not, but calmly state your case with supporting objective evidence if possible.
    • Be honest while answering questions, and if you don’t know the answer, admit it instead of making up a response. Provide supporting documentation and records for all your responses.

Continuous process verification is an important aspect of preparation and planning, leaving you no reason for fear or worry during an FDA inspection. RS Calibration can help you with FDA process validation, process verification, guidance and compliance requirements and calibration services. Contact us before your next audit or inspection!

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