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

Source: https://www.globalkeysolutions.net/records/483/atlas-pharmaceuticals-llc/a29c76ac-dbc8-423f-a1a5-777f72895391

> FDA 483 for Atlas Pharmaceuticals, LLC on September 26, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlas Pharmaceuticals, LLC
- Inspection Date: 2017-09-26
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: 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

## Related Documents

- [483 - 2017-09-26](https://www.globalkeysolutions.net/records/483/atlas-pharmaceuticals-llc/1c4fd93a-68ca-4143-ace6-f9ea59ee41c7)
- [483 - 2021-05-21](https://www.globalkeysolutions.net/records/483/atlas-pharmaceuticals-llc/a96baa6d-6f33-42ff-8a34-7d55764d8424)

Company: https://www.globalkeysolutions.net/companies/atlas-pharmaceuticals-llc/7b618171-3e86-446f-9986-329dbadf7ac5

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7