Readying for a US FDA Inspection.

Are you manufacturing and exporting Medical Devices, Cosmetics, or nutraceuticals to USA, your facility is eventually going to be inspected by the U.S. Food and Drug Administration (FDA).

The Federal Food, Drug and Cosmetic Act states that domestic and foreign establishments can be inspected at least one time every two years. The inspections can happen more frequently, such as if the item you are producing is new, or if your facility has a history of cGMP problems or your products are sold in huge quantities across USA.
An FDA inspector or auditor can enter, observe, gather samples, interview your employees and review records that are related to the manufacturing and related process.
1. What can be FDA inspector or auditor looking for?
a. Is the facility following cGMPs?
b. Does the facility have proper SOPs for all operations and are they being followed?
c. Is the staff fully knowledgeable and familiar with both FDA regulations and cGMPs?
d. Is proper documentation available that shows proper training, monitoring and compliance?
2. SOP Tips
FDA regularly issues 483 inspectional observations regarding failure to keep accurate records and to establish and maintain SOPs. Often, the failure to create and maintain such records is due to having procedures that do not support your operational processes, or do not even exist at all.
3. How to prepare for US FDA Inspection.
a. Bring in an expert to find the GAPS if any
b. Convert QA department to a War room
c. Awareness among the top management to lower level people in the organization
d. Fill the GAPS Identified by the Expert
e. Take the help of an Expert for support till completion of US FDA Audit.
4. After the US FDA Inspection.
After the audit, a good way to avoid a 483 is to respond to the observations as fast and completely as you can. Demonstrate that you have your evidences in the right place handled by respective process owners. It is very important you MUST respond to 483 observations in 15 days, or FDA will not even open your response, means you are easily flushing out lot of money and valuable time.
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Reference Documents

Medical Device   -  21 CFR 820
Food   -   21 CFR 110
Drugs -  21 CFR 211

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