# FDA 483 - ProMed Pharma, LLC - October 17, 2023

Source: https://www.keypedia.com/records/483/promed-pharma-llc/4f966410-a24b-4abd-85b0-b94f14f123d3

> FDA 483 for ProMed Pharma, LLC on October 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ProMed Pharma, LLC
- Inspection Date: 2023-10-17
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of ProMed Pharma, LLC in Plymouth, MN, a drug manufacturer, revealed a significant quality system deficiency. The firm failed to adhere to its own written procedures for conducting annual product reviews, which were established in a technical and quality agreement and detailed in an internal Standard Operating Procedure. This indicates a lapse in ensuring consistent product quality and compliance with regulatory expectations.

## Related Documents

- [483 - 2024-02-21](https://www.keypedia.com/records/483/promed-pharma-llc/2453cf32-1f82-4495-926e-cc8e90cf4eed)

## Related Officers

- [GDUFA Pharmaceutical Investigator](https://www.keypedia.com/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)

Company: https://www.keypedia.com/companies/promed-pharma-llc/6c90c728-0e76-4c0a-8975-59ee146d3393

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d