# FDA 483 - Sharp Clinical Services, LLC - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/sharp-clinical-services-llc/65c8c69b-0fb2-4606-b6a8-99538bebdd00

> FDA 483 for Sharp Clinical Services, LLC on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sharp Clinical Services, LLC
- Inspection Date: 2022-09-02
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Sharp Clinical Services in Bethlehem, PA, a repacker/relabeler and test lab, was cited for five significant violations during an FDA inspection. The observations primarily concern inadequate quality control procedures, including insufficient testing of in-process materials, unvalidated seal integrity methods, lack of proper stability testing for expiration dates, and poorly defined in-process controls and cleaning procedures. These issues indicate a systemic failure to adhere to good manufacturing practices, with one observation being a repeat finding.

## Related Documents

- [483 - 2019-08-30](https://www.globalkeysolutions.net/records/483/sharp-clinical-services-llc/7cfd9b6e-a36a-4ab8-962d-df2a4b434d60)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/terry-bridgewater/59dfea35-4435-47b1-ac4a-0eb6eaf83bc8)
- [William Leonard](https://www.globalkeysolutions.net/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

Company: https://www.globalkeysolutions.net/companies/sharp-clinical-services-llc/d1817364-b3cb-41a2-818e-dea1083e5827

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64