# FDA 483 - PEL Healthcare LLC - January 13, 2023

Source: https://www.keypedia.com/records/483/pel-healthcare-llc/e671146b-2f23-4e31-acb1-d4b2d2077111

> FDA 483 for PEL Healthcare LLC on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PEL Healthcare LLC
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: PEL Healthcare LLC, a drug product manufacturer in Sellersville, PA, was cited for significant deficiencies in its quality system and laboratory controls during an FDA inspection. Observations included a failure to thoroughly investigate unexplained discrepancies and out-of-specification results, as well as inadequate laboratory control procedures for chromatographic analyses and equipment calibration. These issues raise concerns about the scientific soundness and reliability of product release testing.

## Related Documents

- [483 - 2018-04-24](https://www.keypedia.com/records/483/pel-healthcare-llc/3d458a71-6c08-4fad-8377-38ed94068d16)

## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)
- [issuing_officer](https://www.keypedia.com/people/ko-min/767a6604-9a34-49c7-8462-c763c2689f61)

Company: https://www.keypedia.com/companies/pel-healthcare-llc/d3d3b397-8bab-4f88-af83-ce4568b55e00

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