An FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483. The Form 483 is officially known as the "Notice of Inspection Observations."
In order to avoid compliance issues and a potential warning letter from an FDA inspection, you need to keep your QA system in compliance on an ongoing basis. GMP Trends® is an important tool in helping you achieve this goal by providing you and your staff information on how the FDA is currently interpreting the GMP regulations.