This article looks at what you need to do after receiving a warning letter from a regulatory authority, such as the U.S. FDA. This includes the following:
- Best practice in your GMP remediation program
- The warning letter
- Inspection readiness
- Managing difficult questions
The period after an FDA inspection can be a time of joy or pain. However, if your FDA Form 483 is lengthy, you can assume that you will receive an FDA warning letter.
