# FDA 483 - Medical Chemical Corporation - February 18, 2025

Source: https://www.globalkeysolutions.net/records/483/medical-chemical-corporation/753901f6-35e4-4211-b0b2-84be2cbf10a2

> FDA 483 for Medical Chemical Corporation on February 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Chemical Corporation
- Inspection Date: 2025-02-18
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Medical Chemical Corporation in Torrance, CA, a drug manufacturer, received an FDA Form 483 with eight observations highlighting significant deficiencies across its quality systems. Key issues include inadequate component identity and quality testing, lack of process and water system validation, incomplete batch production records, and insufficient investigations into out-of-specification results, all indicating a failure to assure drug product quality.

## Related Documents

- [483 - 2022-03-25](https://www.globalkeysolutions.net/records/483/medical-chemical-corporation/d85af690-10b8-48c7-b5a9-41f809b3f3c2)
- [WARNING_LETTER - 2025-02-18](https://www.globalkeysolutions.net/records/warning_letter/medical-chemical-corporation/040406e6-8113-481a-b54c-0d7a346a4fdf)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

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

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