# FDA 483 - Sharp Packaging Services, LLC - September 12, 2025

Source: https://www.keypedia.com/records/483/sharp-packaging-services-llc/0edf3af7-e1e4-425e-8f0a-d183304625f8

> FDA 483 for Sharp Packaging Services, LLC on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sharp Packaging Services, LLC
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Sharp Packaging Services, LLC in Macungie, PA, a human drug repacker, was cited with two observations during an FDA inspection. The firm failed to follow its written procedures regarding equipment cleaning and maintenance, specifically lacking documentation for re-cleans and personnel involved. Additionally, the firm did not ensure adequate training documentation for temporary employees engaged in primary product packaging operations.

## Related Officers

- [Kara J. Wright](https://www.keypedia.com/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.keypedia.com/companies/sharp-packaging-services-llc/d40ce30f-0218-4c96-aecc-c6b042b53d90

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