Misbranding, Unlicensed biological product, and many other offences: FDA Warning Letter

In September 2023, the FDA inspected an American company; INCELL Corporation LLC manufacturing a product based on amniotic fluid, uncovering serious violations:

1. Unauthorised Drug & Unlicensed Biological Product
• The product is classified as a drug but lacks FDA approval or a Biologics License Application (BLA), violating the FD&C Act and PHS Act.
2. CGMP Violations
• No aseptic process validation: No sterility testing, process validation, or contamination control.
• Lack of identity testing: No scientific quality control for product composition.
• False shelf-life claims: No stability testing to support expiration dates.
3. Misleading Labeling
• The product is misbranded, falsely described as a medical device, with inconsistent shelf-life claims.
4. Environmental Concerns
• Inadequate cleanroom monitoring, failing to track contamination risks.

FDA Actions & Requirements

The FDA demands:

• BLA submission
• Aseptic process validation
• Proper stability & identity testing
• Corrective actions on mislabeled products
• Enhanced environmental monitoring

Failure to comply may result in legal action or product bans.

12-03-2025