# FDA 483 - Medical Chemical Corporation - March 25, 2022

Source: https://www.keypedia.com/records/483/medical-chemical-corporation/d85af690-10b8-48c7-b5a9-41f809b3f3c2

> FDA 483 for Medical Chemical Corporation on March 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Chemical Corporation
- Inspection Date: 2022-03-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Medical Chemical Corporation, a medical device manufacturer in Torrance, CA, revealed significant deficiencies in their quality system. Observations included a lack of validation for a critical manufacturing line, inadequate design change procedures, and failures in complaint handling, supplier qualification, and employee training. One of the training-related observations was a repeat finding, indicating persistent issues.

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## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/medical-chemical-corporation/45260244-951f-4dd1-bd75-f3fb9c37d889

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