# FDA 483 - McGuff Pharmaceuticals, Inc. - March 26, 2019

Source: https://www.globalkeysolutions.net/records/483/mcguff-pharmaceuticals-inc/9fd8866c-51b6-4238-b894-3feaf84f29af

> FDA 483 for McGuff Pharmaceuticals, Inc. on March 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McGuff Pharmaceuticals, Inc.
- Inspection Date: 2019-03-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: McGuff Pharmaceuticals, Inc. in Santa Ana, CA, a sterile drug manufacturer, was cited with seven observations during an FDA inspection from March 18-26, 2019. The inspection revealed significant deficiencies in quality control, including inadequate investigations, untimely implementation of CAPAs, insufficient laboratory controls, incomplete employee training, and failures in environmental monitoring and equipment maintenance. Repeat observations from a previous inspection indicate persistent issues with training and microbiological contamination prevention.

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## Related Officers

- [Laboratory Director](https://www.globalkeysolutions.net/people/jennifer-m-gogley/2025f306-80a6-4222-89ac-e4138028292a)
- [Pharmaceutical investigator](https://www.globalkeysolutions.net/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)
- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.globalkeysolutions.net/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)

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