# PPL Healthcare LLC – FDA 483, May 8, 2026

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

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

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## Details

- Record Type: 483
- Company Name: PPL Healthcare LLC
- Inspection Date: 2026-05-08
- Product Type: drugs
- Office Name: Philadelphia District Office
- 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 - 2023-01-13](https://www.keypedia.com/records/483/ppl-healthcare-llc/e671146b-2f23-4e31-acb1-d4b2d2077111) — date: January 13, 2023
- [EIR - 2018-04-24](https://www.keypedia.com/records/eir/ppl-healthcare-llc/508b0114-f0dd-428f-8c68-a37585f5c17b) — date: April 24, 2018
- [483 - 2018-04-24](https://www.keypedia.com/records/483/ppl-healthcare-llc/3d458a71-6c08-4fad-8377-38ed94068d16) — date: April 24, 2018

## 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/ppl-healthcare-llc/d3d3b397-8bab-4f88-af83-ce4568b55e00

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