# FDA 483 - McGuff Company Inc. - March 09, 2022

Source: https://www.globalkeysolutions.net/records/483/mcguff-company-inc/88d9f3a9-de57-4bdc-9c38-298324024b91

> FDA 483 for McGuff Company Inc. on March 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McGuff Company Inc.
- Inspection Date: 2022-03-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: McGuff Company Inc., a manufacturer in Santa Ana, CA, was inspected by the FDA, revealing a significant quality system deficiency. The firm failed to clearly define the type and extent of control over its suppliers. This included a lack of written specifications and quality requirements for a Class II medical device it has been purchasing and distributing.

## Related Officers

- [Kevin N. Tran](https://www.globalkeysolutions.net/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.globalkeysolutions.net/companies/mcguff-company-inc/0e7de712-3f66-4fea-8bfe-f851677e46a4

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