The US Food and Drug Administration (FDA) inspects facilities to ensure their compliance with regulations and lays surrounding the manufacture, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the US. FDA Inspections are conducted on both local and foreign establishments as long as the products are intended for US distribution.
You will not always be informed about an FDA inspection in advance, so you need to be fully prepared if you want to avoid those pesky warning letters and citations! (Form 483).
The FDA (Food & Drug Administration) has gotten more stringent with their acceptance criteria, especially when it comes to food and drug or medical device companies.
Here are a few tips to help you prepare:
Perform an internal Quality Audit
Internal quality audits help you to identify possible compliance problems and areas of concern, so you can adjust procedures and processes as required. An internal auditing program is ideal for ensuring that individual processes and your entire quality system does meet FDA process validation and compliance requirements.
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 is not enough to draft procedures that comply with FDA approval requirements. 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 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.
Ensure Your Team is Fully Prepared
FDA inspections are stressful, even when you are prepared for them. Consider, looking 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.
Define roles and responsibilities for employees who will be involved in the inspection, and coach them on answering questions directly and responding specifically to what is asked.
Do not Panic Before an Inspection
A little panic is normal but 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 always 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 do not understand the inspector’s comments, ask for clarification instead of trying to guess at what they mean.
- If you do not agree with observations, avoid being argumentative or defensive. You must 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 do not know the answer, admit it instead of making up a response. Provide supporting documentation and records for all your responses.
Verification of data integrity is a critical part of the FDA's mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. Enforcement actions by the FDA with respect to data integrity-related cGMP violations can result in serious financial consequences for any organization due to facility shutdown, product recalls, import and/or distribution bans, delayed or denied drug approvals substantial remediation costs, and loss of customers due to a damaged reputation.
This FDA Inspection Preparation Checklist or USFDA Audit Checklist can be used to track the preparedness of a site or facility for an upcoming FDA inspection. Managers can use this as an aid to prepare the personnel, site, and documentation needed before an inspection. Use this as a guide for the following: ( FDA INSPECTION: Preparedness Checklist )
1. Verify the preparedness of staff, facility, equipment, and all the relevant documents.
2. Notify and assign tasks to the right colleagues who can work on areas or items needed for the FDA inspection.
3. Identify red flags to help prioritize what still needs to be done.
4. Measure the readiness of the facility using scoring.
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Our skilled staff members understand the nuances of instrument calibration and the manufacturers train our technicians, so any inspections we make mean your equipment is to quality standards. For more than 30 years, SIC has served businesses that use a wide variety of diagnostic and scientific equipment. As a leader in Scientific Equipment Reaper and medical device calibrations, we work with many corporations, universities, and hospitals. We are specialists.Get a free consultation. Call (800) 686-8965
