FDA 483 - Atlas Pharmaceuticals, LLC - September 26, 2017

The FDA Form 483 details numerous deficiencies at a pharmaceutical facility, particularly concerning sterile drug product manufacturing and quality control.

**Key Violations and Observations:**

* **Microbiological Contamination Prevention:** Procedures for preventing microbiological contamination of sterile drug products are not established, written, or followed. * **Media Fill Failures:** The firm failed to investigate a media fill failure (Lot (b)(4), 06/06/2017) with Bacillus licheniformis contamination, and did not determine the root cause. Subsequent media fill repetitions by Operator (b)(6) were not full batch sizes as required, and the procedure "S-09 Media Fill Trial" lacks guidance for repeating failed trials. A media fill (Lot (b)(4), 08/30/2017) had a vial removed prematurely, preventing full incubation. * **Aseptic Processing Environment:** * Smoke studies (05/22/2017) were not performed under dynamic conditions and showed non-unidirectional airflow with turbulence and slow airflow in critical areas. * Material transfer from ISO 8 to ISO 7 areas (09/19/2017) lacked decontamination procedures for items like glassware, tubing, and bulk solutions. * Environmental monitoring records for viable air, surface, and personnel samples are deficient, lacking pass/fail specifications and results for