# FDA 483 - Almac Clinical Services, LLC - December 22, 2017

Source: https://www.keypedia.com/records/483/almac-clinical-services-llc/031b3e61-c6cf-465f-bbce-5a38af5978c6

> FDA 483 for Almac Clinical Services, LLC on December 22, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Almac Clinical Services, LLC
- Inspection Date: 2017-12-22
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Almac Clinical Services, LLC in Souderton, PA, a contract testing lab, was cited for deficiencies in its quality control unit during an FDA inspection. The firm failed to ensure the timely review of standard operating procedures (SOPs). Multiple site-specific and Almac Sciences procedures were found to be significantly overdue for review, indicating a lapse in document management and quality system adherence.

## Related Officers

- [Investigator](https://www.keypedia.com/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)
- [Sam Pepe](https://www.keypedia.com/people/sam-pepe/3e375dc5-b5af-4d79-a6f3-cded803aee7a)

Company: https://www.keypedia.com/companies/almac-clinical-services-llc/865d4a20-0e85-410e-bbbf-b9c724879db4

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