503B cGMP Inspection

Are you really ready for your initial or follow up 503B cGMP Inspection?

Most 503B outsourcing facilities would assume they are ready for inspection, but often this is not the case.  Thus far in 2018 – FDA has issued 62 Form 483’s to 503B Outsourcing Facilities at the conclusion of the 503B cGMP inspection.

  • Q1 – 22 facilities received a Form 483
  • Q2 – 23 facilities received a Form 483
  • Q3 (as of Sept 11) – 17 facilities have received a form 483

What is a FDA Form 483?  As reported on the FDA website, FDA Form 483 Fequently Asked Questions:

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.

What is the purpose of the Form 483?

The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

Is the Form 483 all inclusive of everything wrong at my site?

No, it’s not. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.

If I receive a Form 483 what happens next?

The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.

For 30 years Performance Validation has been assisting the life science industry in meeting FDA regulations.  Are you interested in performing a pre-inspection assessment?  Are you working on a remediaion plan and looking for an independent review to check the effectiveness of corrections or corrective actions?  Do you need assistence in performing a specific correction for example Critical Airflow Visualization, or Temperature Mapping of your Autoclave, Oven, or USP Storage areas?  Have a question, looking for answers, contact Performance Validation.