The FDA just called notifying you of their upcoming site visit! Now what?
An FDA Inspection Audit can occur at any time. Below are tips you can use to ensure that the site visit goes smoothly for all parties involved. The key is to always be prepared for an FDA audit. However, if you are not, here are some guidelines you can follow that will help you to avoid the possibility of a Form FDA 483, inspectional observations.
Before the Audit
Confirm the time and place of the FDA audit to ensure that the right people are preparing for the FDA visit, and then plan working rooms for the inspectors and audit support. Map out your site tour, and inform all employees that this tour will be taking place. Confirm that all employees know which procedures and/or work instructions they should reference for their specific jobs, and where to locate them. It is important to make sure that job descriptions and training records are available for each employee as well.
It is useful to remind employees how to interact when approached and questioned by the auditor. Make sure that your employees know that best practice is to answer only the specific question asked by the auditor- and if they don’t know the answer to a question, it is always best to respond “I do not know the answer, but let me find out for you”. The goal is to have precise, accurate answers to an auditor’s questions.
We highly encourage clients to create a folder of documents and records that the FDA is likely to request. Preparing these documents ahead of time saves time for both the auditor and the auditee. Documents we recommend locating and pulling into this folder include:
- Quality Manual
- Organization Chart, Responsibilities Matrix
- Job Descriptions and Training Records
- CAPAs and Complaints
- Device Listings
- Key Procedures including Management Review, CAPA, Design Control, Risk Management, Production and Process Controls
During the Audit
Remind employees at the site that the audit will be conducted that day. Make sure that the auditor is escorted by a company employee at all times. Remember to be respectful towards the auditor and to keep answers concise and honest.
Quick document turnaround time is a major key to a successful audit. Try your best to locate documents that the auditor has requested as quickly as possible. This is why RookQS so heavily encourages document preparation in advance of the audit date.
As nonconformances are noted by the auditor during the audit, make efforts to immediately correct if at all possible.
After the Audit
If a 483 is issued, a written response should be submitted within 15 days and needs to include the following information:
- Background information relating to the observation
- Root cause assessment of the problem or commitment for further investigation if additional time is needed, including a target dates for completion
- Corrective and Preventive actions, immediately corrected if possible with completion dates and objective evidence
- Provide a reasonable timeline for the correction
- Commitment to provide a follow-up response, per specific date, if all actions cannot be completed prior to the 15-day submission timeline for the initial response
Be sure to maintain a signed copy of the final response to the 483 issued for your records.
A huge key to a successful FDA inspection is knowing what to expect and how to prepare. RookQS has a team of 20+ engineers who have assisted numerous clients with completing successful FDA audits. Reach out to us to learn more about how we can assist you with yours! Not expecting the FDA anytime soon? We have seen firsthand the benefits of being prepared for the FDA at any moment, and making these preparations as early as possible: We’re here to help you establish a system to maintain preparedness.