FDA Form 483 Response in USA

FDA conducts inspections of food facilities periodically. At the end of the inspection, the FDA issues a Form 483 which includes observations by the inspector, that he/she believes violates the Food Drug & Cosmetic Act (FD&C). The inspector discusses the inspection findings with the operator, owner, or senior management of the facility. Companies must respond to the FDA Form 483 with their corrective action plan and then implement that corrective action plan.

You must curate an FDA Form 483 response within 15 business days. Failure to respond may lead to increased surveillance and a warning letter. In case of serious violations, the FDA can issue a Consent Decree, which will lead to legal consequences, hefty fines, and/or shutdown of the organization.

It’s worthwhile to mention here that form 483 is just a chance to grow from your faults and enhance your operations by attending to and addressing the identified problems. Simply said, it’s someone observing your procedures from the outside telling you to “look into this issue and make the needed corrections.”

GHP has experts having 15 years of experience in helping companies respond to 483s as consultants and can help your food facility to clear the observations made by the FDA and bring your company back in compliance by drafting an effective FDA Form 483 response in a timely manner.

After the response, GHP will assist your facility to implement the corrective actions and the preventive actions necessary to keep your facility ready for the next FDA inspection.