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

Source: https://www.keypedia.com/records/483/atlas-pharmaceuticals-llc/1c4fd93a-68ca-4143-ace6-f9ea59ee41c7

> 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: Division of Pharmaceutical Quality Operations IV
- Summary: Atlas Pharmaceuticals, LLC, an outsourcing facility in Phoenix, AZ, was cited with 11 observations for significant deficiencies in its manufacturing processes for sterile drug products. The findings indicate a systemic lack of control over microbiological contamination, environmental monitoring, sanitation, personnel training, and quality control, posing serious risks to product sterility and patient safety. Key issues include media fill failures, inadequate sterilization validations, poor environmental monitoring, and improper material handling.

## Related Documents

- [483 - 2017-09-26](https://www.keypedia.com/records/483/atlas-pharmaceuticals-llc/a29c76ac-dbc8-423f-a1a5-777f72895391)
- [483 - 2021-05-21](https://www.keypedia.com/records/483/atlas-pharmaceuticals-llc/a96baa6d-6f33-42ff-8a34-7d55764d8424)

## Related Officers

- [Stephanie A. Slater](https://www.keypedia.com/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6