# FDA 483 - Medical Products Laboratories, Inc. - October 16, 2025

Source: https://www.keypedia.com/records/483/medical-products-laboratories-inc/5760b543-20ff-40e8-880e-640a085dbfd3

> FDA 483 for Medical Products Laboratories, Inc. on October 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Products Laboratories, Inc.
- Inspection Date: 2025-10-16
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Medical Products Laboratories, Inc. in Philadelphia was cited for significant Good Manufacturing Practice (GMP) violations during an FDA inspection. The firm failed to establish adequate production and process controls, including unvalidated manufacturing processes and formulation changes, and exhibited a lack of thorough investigations into product complaints and microbial contamination. Additionally, the quality control unit demonstrated a lack of authority by improperly handling stability failures and releasing products without sufficient scientific justification.

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- [WARNING_LETTER - 2025-10-16](https://www.keypedia.com/records/warning_letter/medical-products-laboratories-inc/319e930f-6222-41bb-9be6-019b24ec0895)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/medical-products-laboratories-inc/7e417525-325c-4b38-9007-cee432ed2387

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8