An important way to avoid receiving an FDA 483 after an inspection is to be prepared for your audit.
Being prepared means you are up to date on the latest regulations and FDA inspector’s interpretation of them.
You can request FDA 483s through the Freedom of Information Act, you can read all the reports, you can compile the observations and determine which ones are happening most frequently or you can subscribe to the GMP Trends publications where we do the work for you.
GMP Trends has multiple reports to help keep you in compliance.
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