FDA WARNING_LETTER - Horizon Pharmaceuticals, Inc. - November 05, 2015

The FDA issued a Warning Letter to Horizon Pharmaceuticals, Inc. following an inspection from October 27 to November 5, 2015, at their Riviera Beach, Florida, drug manufacturing facilities. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b))**: The firm distributed non-sterile Saljet ophthalmic drug product lots (4J009, 4J010, 4J011) after re-testing, despite initial positive sterility results for *Bacillus mycoides*. Deficiencies included a lack of sporicidal agents in the cleaning program, leaking pipes, and cracked floors. The FDA requires a comprehensive assessment of aseptic manufacturing, a CAPA plan, and evaluation of other impacted lots. 2. **Inadequate investigation of discrepancies/failures (21 CFR 211.192)**: * **Saljet (HPI-087)**: The firm released contaminated lots without scientific justification for invalidating positive sterility tests, despite *Bacillus mycoides* being found in cleanrooms. The investigation lacked evaluation of manufacturing processes, facility conditions, and utility systems. The FDA demands a comprehensive investigation, risk analysis of affected batches, and media fill/sterility