# FDA 483 - Specialty Process Labs LLC - January 26, 2024

Source: https://www.keypedia.com/records/483/specialty-process-labs-llc/1436f938-c6a5-4346-9eef-306ff096cd13

> FDA 483 for Specialty Process Labs LLC on January 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Process Labs LLC
- Inspection Date: 2024-01-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Specialty Process Labs LLC, an API manufacturer in Phoenix, AZ, was cited for significant deficiencies across its operations. The inspection revealed inadequate validation of manufacturing processes and microbiology lab equipment, a failure to investigate out-of-specification stability results, and insufficient equipment cleaning validation. Furthermore, the firm demonstrated a severe lack of data integrity controls for electronic records and critical quality unit failures, including unclosed CAPAs and unvalidated microbiological testing methods.

## 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 - 2023-09-15](https://www.keypedia.com/records/483/specialty-process-labs-llc/5bb498a4-e227-415f-a3dc-211fadcee30e)
- [483 - 2025-07-21](https://www.keypedia.com/records/483/specialty-process-labs-llc/5bd38cd8-8492-422c-8024-e3e9b24ca731)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [Philip F. Istafanos](https://www.keypedia.com/people/philip-f-istafanos/c2fcfe52-1070-4551-bffc-f8bcfad5b30b)

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

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