# FDA 483 - Medical Products Laboratories, Inc. - March 13, 2020

Source: https://www.globalkeysolutions.net/records/483/medical-products-laboratories-inc/8c9064cb-41b5-4889-91f0-74bef06191ce

> FDA 483 for Medical Products Laboratories, Inc. on March 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Products Laboratories, Inc.
- Inspection Date: 2020-03-13
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Medical Products Laboratories, Inc. in Philadelphia, PA, a contract manufacturer of Rx and OTC drug products, was cited with five observations during an FDA inspection from February 24 to March 13, 2020. The inspection revealed significant deficiencies in quality control unit procedures, investigation processes for discrepancies and complaints, equipment cleaning validation, process control documentation, and laboratory controls for water system specifications. These issues indicate a lack of adherence to cGMP requirements, potentially impacting product quality and safety.

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## Related Officers

- [Richard D Oyeleke](https://www.globalkeysolutions.net/people/richard-d-oyeleke/c5ca4d32-74fa-4028-b9ba-4b15fe356898)
- [Allison Aldridge](https://www.globalkeysolutions.net/people/allison-aldridge/a5482953-0d65-46b5-8cc7-70f75f886e07)
- [Rachael D Oyeleke](https://www.globalkeysolutions.net/people/rachael-d-oyeleke/7675c425-dc26-4a58-9f48-d39a586d50ce)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

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

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