# FDA 483 - Medical Products Laboratories, Inc. - July 21, 2015

Source: https://www.keypedia.com/records/483/medical-products-laboratories-inc/c6938055-8006-4079-bbfd-bcfb6c699e53

> FDA 483 for Medical Products Laboratories, Inc. on July 21, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Products Laboratories, Inc.
- Inspection Date: 2015-07-21
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Medical Products Laboratories, Inc. in Philadelphia, PA, revealed significant deficiencies in their manufacturing processes, laboratory controls, and material handling. Observations included unapproved production interventions, inadequate documentation of critical parameters, insufficient standard solution preparation for HPLC analysis, and improper control of rejected materials, with the latter being a repeat observation. These issues indicate a lack of adherence to established procedures and quality standards.

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## Related Officers

- [Deborah J. Parris, Investigator](https://www.keypedia.com/people/deborah-j-parris-investigator/4385508e-9b3e-4699-a048-591d39b84324)
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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