NeilMed Pharmaceuticals Inc. – FDA Warning Letter, Dec 2, 2022

The FDA inspected NeilMed Pharmaceuticals Inc. from November 28 to December 2, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Violations include: 1. **Failure to test components:** The firm did not conduct identity testing for each component, specifically glycerin and other high-risk components, for hazardous impurities like diethylene glycol (DEG) or ethylene glycol (EG). They relied on unqualified supplier COAs. Their response was inadequate as it didn't address glycerin lots already in inventory or distributed products. 2. **Inadequate equipment cleaning and maintenance:** Unidentified visible residues were observed on "Cleaned" mixing tanks, and cleaning/usage logs were not maintained. This is linked to multiple findings of objectionable microbial contamination (e.g., *Burkholderia cepacia complex*, yeast, mold) in finished drug products. The firm's CAPA was deemed insufficient for not comprehensively assessing cleaning effectiveness, potential cross-contamination, or oversight failures.

Additional concerns include deficiencies in investigating out-of-specification (OOS) bioburden results, as investigations were not extended to all potentially impacted batches, and CAPAs were not timely or effective.

The FDA strongly recommends engaging a CGMP consultant. The firm must promptly correct all violations, investigate root causes, and prevent recurrence. Failure to adequately address these issues within 15 working days may result in regulatory action, including