FDA Warns INCELL Corporation Over Violations in Amniotic Fluid Product

Following an inspection from 25–29 September 2023, the FDA issued a warning to an American company manufacturing an amniotic fluid-based product, citing serious regulatory violations.

Key Issues Identified:

1. Unauthorised Drug & Unlicensed Biological Product
• The product lacks FDA approval and a Biologics Licence Application (BLA), making its marketing illegal under the FD&C Act and PHS Act.
2. Good Manufacturing Practice (CGMP) Violations
• Aseptic Process Validation: No sterility assurance or process simulations.
• Identity Testing: No scientific specifications for product composition.
• Stability Testing: No data-backed shelf-life validation, leading to mislabeling.
3. Misleading Labeling
• The product’s classification and shelf-life claims contradict FDA regulations, creating safety risks.
4. Environmental Concerns
• Inadequate cleanroom monitoring, risking microbial contamination.

FDA Demands & Consequences

The FDA requires corrective actions, including:

• BLA submission
• Validated aseptic processes & testing
• Accurate labeling & environmental monitoring

Failure to comply could lead to product bans and legal action. Read the full FDA warning to INCELL Corporation LLC online.

03-04-2025

• Pharma GMP
• Food GMP
• Clinical Research
• Medical Device
• Environmental Health and Safety
• Healthcare
• Nutrition