How prepare for FDA inspection?

If you’re like most small businesses, you probably don’t give the Food and Drug Administration (FDA) much thought. But if you’re a business that makes or sells food, drugs, medical devices, or any other type of FDA-regulated product, it’s a good idea to familiarize yourself with the agency and its inspection process.

Here are four tips for preparing for an FDA inspection:
1. Have a clear idea of what your product can and cannot be. Make sure all labels are accurate and up-to-date and all ingredients are listed correctly. If your product falls under the prohibited category, you cannot sell it.

2. Be prepared to provide documentation verifying that your product complies with all regulations This may include copies of labels, packaging materials, third-party testing agency certifications, or any other relevant information.

3. Keep all necessary equipment and supplies ready for use, including clean lab space and proper sterilization procedures for all equipment. The FDA may require you to submit samples for testing, and you may not be able to do so without the proper equipment.

4. Familiarize yourself with the FDA inspection process. The agency will take certain steps during an inspection and you need to know what they are to avoid surprises.

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