AMRI Burlington, Inc. (formerly Hyaluron, Inc.) – FDA Warning Letter, Apr 1, 2010

On August 17, 2010, the FDA issued a Warning Letter to Albany Molecular Research, Inc. (AMRI Burlington, Inc.) following an inspection from March 2 to April 1, 2010. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR § 211.192):** The firm failed to thoroughly investigate particulate contamination in multiple drug product lots (e.g., (b)(4) injection, (b)(4), (b)(4)), not extending investigations to other batches or conducting formal risk assessments. The firm's response was deemed inadequate for failing to identify root causes and evaluate other potentially contaminated products. 2. **Failure to Prevent Microbiological Contamination (21 CFR § 211.113(b)):** Investigators observed poor aseptic techniques by manufacturing and quality control personnel (e.g., improper handling of stoppers, wiping gowns on the floor, incorrect glove removal). Deficiencies in environmental and personnel monitoring were noted (e.g., unsterile garments on benches, incorrect fingertip monitoring). Procedures for sterilizing tools, bringing communication radios into aseptic suites, and autoclaving batch record paper were also lacking. 3. **Invalid In-Process Specifications (21 CFR § 211