Cangene BioPharma, LLC – FDA Warning Letter, Feb 18, 2022

The FDA issued a Warning Letter to Cangene BioPharma, LLC dba Emergent BioSolutions, following an inspection from February 7-18, 2022, at their Baltimore, MD facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to clean and maintain equipment (21 CFR 211.67(a) and (b))**: The firm used unsuitable equipment (tray units) for aseptic manufacturing, leading to metal and silicone particulate contamination in sterile drug products. Investigations linked particulates to damaged tray units, which were deemed "intrinsic" to the process without adequate corrective action. The firm's procedure for tray unit maintenance was deficient, lacking specific documentation for inspection, segregation, and repair/retirement of defective units. The FDA found the firm's response inadequate, lacking evidence of tray unit suitability, a systemic review of preventive maintenance, documentation of actions on defective units, and a plan for tracking units or adequately investigating intrinsic/extrinsic particulate contamination.

2. **Failure to prevent microbiological contamination in sterile products (21 CFR 211.113(b))**: Investigators observed poor aseptic techniques by operators during interventions in aseptic filling line operations, and inadequate storage of sterile materials. The firm's SOP