# FDA 483 - Specialty Process Labs LLC - September 15, 2023

Source: https://www.keypedia.com/records/483/specialty-process-labs-llc/5bb498a4-e227-415f-a3dc-211fadcee30e

> FDA 483 for Specialty Process Labs LLC on September 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Process Labs LLC
- Inspection Date: 2023-09-15
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Specialty Process Labs LLC in Phoenix, AZ, an API manufacturer, was cited for three significant issues during an FDA inspection. These included the quality unit's failure to ensure timely destruction of recalled drug products, a lack of documented procedures and control over laboratory samples and data, and the absence of a proper stability testing program for intermediates and APIs. The findings indicate serious deficiencies in quality control and data integrity.

## Related Documents

- [483 - 2021-11-19](https://www.keypedia.com/records/483/specialty-process-labs-llc/fbac821d-896a-48a4-b912-b89e7c58d04b)
- [WARNING_LETTER - 2021-11-19](https://www.keypedia.com/records/warning_letter/specialty-process-labs-llc/e2c96ccb-8f3a-4f59-9a86-7f1f4c55b44a)
- [483 - 2024-01-26](https://www.keypedia.com/records/483/specialty-process-labs-llc/1436f938-c6a5-4346-9eef-306ff096cd13)
- [483 - 2025-07-21](https://www.keypedia.com/records/483/specialty-process-labs-llc/5bd38cd8-8492-422c-8024-e3e9b24ca731)

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.keypedia.com/companies/specialty-process-labs-llc/ae8c102e-5f85-4483-9a72-68595475e0ac

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face