# FDA 483 - Almac Pharma Services LLC - December 07, 2017

Source: https://www.globalkeysolutions.net/records/483/almac-pharma-services-llc/ac59593c-8b83-4894-9021-156ca667216a

> FDA 483 for Almac Pharma Services LLC on December 07, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Almac Pharma Services LLC
- Inspection Date: 2017-12-07
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Almac Pharma Services LLC in Audubon, PA, revealed significant deficiencies across multiple areas of their drug repacking and relabeling operations. The firm failed to conduct thorough investigations into product commingling, did not consistently follow quality control procedures for deviations and batch record review, and had inadequately trained personnel. Additionally, the inspection found issues with cleaning validation, maintenance procedures, and the completeness of laboratory records, indicating a need for comprehensive improvements in their quality systems.

## Related Documents

- [EIR - 2022-02-03](https://www.globalkeysolutions.net/records/eir/almac-pharma-services-llc/ae436155-1d2b-4336-b2c8-117cba024b9b)
- [483 - 2022-02-03](https://www.globalkeysolutions.net/records/483/almac-pharma-services-llc/cf8fd558-43c3-47ec-afbe-1c7394d7d5c6)
- [483 - 2025-08-22](https://www.globalkeysolutions.net/records/483/almac-pharma-services-llc/640d5e10-a7ea-4631-aebd-b7508026fdfc)

## Related Officers

- [PreApproval Manager](https://www.globalkeysolutions.net/people/gayle-s-lawson/cd8061de-f089-408c-bbfc-c7c7a5635dd7)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

Company: https://www.globalkeysolutions.net/companies/almac-pharma-services-llc/a5015855-2f01-4474-895d-a397cc89e5fa

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