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

Source: https://www.keypedia.com/records/483/atlas-pharmaceuticals-llc/a96baa6d-6f33-42ff-8a34-7d55764d8424

> FDA 483 for Atlas Pharmaceuticals, LLC on May 21, 2021. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlas Pharmaceuticals, LLC
- Inspection Date: 2021-05-21
- Office Name: Los Angeles District Office
- Summary: 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

## Related Documents

- [483 - 2017-09-26](https://www.keypedia.com/records/483/atlas-pharmaceuticals-llc/1c4fd93a-68ca-4143-ace6-f9ea59ee41c7)
- [483 - 2017-09-26](https://www.keypedia.com/records/483/atlas-pharmaceuticals-llc/a29c76ac-dbc8-423f-a1a5-777f72895391)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b