# FDA 483 - McGuff Pharmaceuticals, Inc. - April 28, 2025

Source: https://www.keypedia.com/records/483/mcguff-pharmaceuticals-inc/3f2a1b4f-952b-4190-8c3c-d5994ef38ea6

> FDA 483 for McGuff Pharmaceuticals, Inc. on April 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McGuff Pharmaceuticals, Inc.
- Inspection Date: 2025-04-28
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: McGuff Pharmaceuticals, Inc. in Santa Ana, CA, a sterile drug manufacturer, was cited for significant deficiencies in its aseptic processing controls and quality unit operations. The inspection revealed a lack of written procedures for preventing microbiological contamination, inadequate cleanroom evaluation, and poor environmental monitoring. Additionally, the quality control unit failed to establish written responsibilities, properly review changes, release raw materials, or adequately investigate discrepancies and evaluate corrective actions.

## Related Documents

- [483 - 2019-03-26](https://www.keypedia.com/records/483/mcguff-pharmaceuticals-inc/9fd8866c-51b6-4238-b894-3feaf84f29af)
- [483 - 2024-01-26](https://www.keypedia.com/records/483/mcguff-pharmaceuticals-inc/8072bd23-3409-41b9-b04a-7dcc8ccd7185)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)
- [Jay-Ar C. Bendo](https://www.keypedia.com/people/jay-ar-c-bendo/c920c6b7-756b-42c7-be52-8b677d192f77)

Company: https://www.keypedia.com/companies/mcguff-pharmaceuticals-inc/15443041-ed2c-4d7b-8313-9c85fa0f7bc6

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