# FDA 483 - PEL Healthcare LLC - May 08, 2026

Source: https://www.keypedia.com/records/483/pel-healthcare-llc/93012da2-4b9a-4698-830a-fc06d13bcff2

> FDA 483 for PEL Healthcare LLC on May 08, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PEL Healthcare LLC
- Inspection Date: 2026-05-08
- Product Type: drugs
- Office Name: FDA District Office — Philadelphia, Pennsylvania
- Summary: PPL Healthcare LLC in Sellersville, PA, was cited with three observations during an FDA inspection. The firm failed to establish adequate specifications for incoming API, leading to undetected contamination in drug products. Additionally, the inspection revealed a lack of proper sanitation for manufacturing equipment, resulting in microbial contamination, and a failure to consistently follow the written stability testing program.

## Related Documents

- [483 - 2018-04-24](https://www.keypedia.com/records/483/pel-healthcare-llc/3d458a71-6c08-4fad-8377-38ed94068d16)
- [EIR - 2018-04-24](https://www.keypedia.com/records/eir/pel-healthcare-llc/508b0114-f0dd-428f-8c68-a37585f5c17b)
- [483 - 2023-01-13](https://www.keypedia.com/records/483/pel-healthcare-llc/e671146b-2f23-4e31-acb1-d4b2d2077111)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [investigator](https://www.keypedia.com/people/daniel-t-lee/8147e5b2-2065-42e3-b86c-36c0231f74cc)

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

Office: https://www.keypedia.com/offices/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0