# FDA 483 - McGuff Pharmaceuticals, Inc. - January 26, 2024

Source: https://www.globalkeysolutions.net/records/483/mcguff-pharmaceuticals-inc/8072bd23-3409-41b9-b04a-7dcc8ccd7185

> FDA 483 for McGuff Pharmaceuticals, Inc. on January 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McGuff Pharmaceuticals, Inc.
- Inspection Date: 2024-01-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: McGuff Pharmaceuticals, Inc. in Santa Ana, CA, a sterile drug manufacturer, received a Form 483 with six observations highlighting significant deficiencies across its quality systems. The inspection revealed inadequate investigations into manufacturing discrepancies, including decontamination cycle failures and particle monitoring excursions, and a failure to timely implement corrective actions. Further issues included an unreliable visual inspection program, unrecorded deviations from production procedures, insufficient employee training, and a lack of adherence to microbial monitoring test procedures and sanitation program documentation.

## Related Documents

- [483 - 2019-03-26](https://www.globalkeysolutions.net/records/483/mcguff-pharmaceuticals-inc/9fd8866c-51b6-4238-b894-3feaf84f29af)
- [483 - 2025-04-28](https://www.globalkeysolutions.net/records/483/mcguff-pharmaceuticals-inc/3f2a1b4f-952b-4190-8c3c-d5994ef38ea6)

## Related Officers

- [Pearl C. Ozuruigbo](https://www.globalkeysolutions.net/people/pearl-c-ozuruigbo/28ec383e-a602-4764-8d14-20b1049f93d7)
- [Microbiologist](https://www.globalkeysolutions.net/people/michael-t-cyrus/30e497e1-2c17-4dd7-9a5b-251771cf4266)
- [investigator](https://www.globalkeysolutions.net/people/heidy-c-perales/fdf71c74-8cb7-41b5-9070-6b8eb11cb404)
- [Crystal Monroy](https://www.globalkeysolutions.net/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

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

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