FDA 483 - Atlas Pharmaceuticals, LLC - May 21, 2021

The FDA Form 483 details significant deficiencies at a drug manufacturing facility producing sterile injectable products.

**Violations and Observations:**

1. **Microbiological Contamination Prevention:** * Procedures for preventing microbiological contamination of sterile drug products are inadequate. * Personnel and environmental monitoring specifications for ISO 5 areas are insufficient. * The environmental monitoring procedure does not consistently require investigations for viable microorganism recovery. * A gloved fingertip sample on 06/17/20 showed growth (redacted CFU) for buprenorphine, 0.15 mg/ml, injection, lot s-60357, but no investigation occurred despite being below the action limit (redacted CFU).

2. **Product Conformance to Specifications (Visual Inspection):** * Visual inspection procedures and personnel training are deficient. * For dexmedetomidine HCl, 1 mg/ml, injection, lot s-60399: * An initial QA inspection found redacted vials with particulates, exceeding the action limit (less than redacted). * A reinspection 15 days later found redacted vials with particulates, below the reinspection action limit (redacted). * The lot was released without a written investigation into the discrepancy between inspections. * The visual inspection procedure (Q-23) does