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FDA inspections are an important part of ensuring the safety and efficacy of products that come into contact with the public. The FDA tests products to ensure they are safe, effective and meet all label requirements.
When you receive notification from the FDA that your product has been recalled, the first step is to take appropriate action to resolve the issue. However, if you do not receive a recall notice, it is important that you take steps to protect your product and your business.
When should you prepare for an FDA inspection? The answer may vary depending on the product you make or sell. However, there are some general tips that can help regardless of your specific situation.
Related: 5,483 Most Common in FDA Inspections
First, always keep accurate records of all your products. This includes not only what is on them, but also what was done to them and when. You will need this information to adequately demonstrate that the changes or repairs were made in accordance with government guidelines.
Also, be sure to keep all packaging and labels up to date. This includes any safety warnings or instructions that the FDA may have issued since your product was last manufactured.
Finally, ensure that all employees are fully aware of government guidelines regarding product recalls and inspections. Make sure they know what information to provide during an inspection and make sure they are prepared to answer any questions the inspector may have.
