Biologics companies that wish to sell product in the United States should be ready at all times for a Food & Drug Administration (FDA) inspection. FDA inspectors have the authority to issue a Form 483 notice, which is a documented form that communicates when a company’s practices are not in compliance with regulatory standards.
When a Form 483 has been received, a quick response is required from the biologic company in conjunction with a remedial plan of action. If a response is not made within a specified time frame, fines, warning letters, or even prison time can be the result. In other words, the seriousness of receiving a Form 483 should not be ignored!
On an annual basis, the FDA releases a report (Fiscal Year 2016 Inspectional Observations Summary) which includes the most common reasons for issuing Form 483 notices to biologics and other life science companies. This report can help guide companies toward improving quality compliance.
For example, the report indicates three common reasons for Form 483s in biologics environments:
- Documentation is inadequate (21 CFR Part 606.100).
- Records are not concurrently maintained (21 CFR Part 606.160).
- Relevant details are not recorded (21 CFR Part 606.160).
GxP Lifeline, in conjunction with MasterControl, provides a white paper which details eight additional reasons why biologics companies receive Form 483s, the specific regulations which should have been followed and advice for preventing FDA 483 notices.
This article directly references the White Paper:
Marci Crane is a regular contributor to GxP Lifeline and has written on subjects related to regulatory compliance in the life science industries for over ten years.