# FDA 483 - AJES Pharmaceuticals, LLC - October 14, 2021

Source: https://www.globalkeysolutions.net/records/483/ajes-pharmaceuticals-llc/87ce17f9-36ed-4d68-90a8-40f1a38d6ba8

> FDA 483 for AJES Pharmaceuticals, LLC on October 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AJES Pharmaceuticals, LLC
- Inspection Date: 2021-10-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: AJES Pharmaceuticals LLC, a dietary supplement manufacturer in Copiague, NY, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in finished product testing, documentation of in-process specifications, laboratory control processes, and quality control procedures, including the release of out-of-specification products. These issues indicate a lack of adequate controls to ensure the identity, purity, strength, and composition of their dietary supplements.

## Related Documents

- [483 - 2018-03-29](https://www.globalkeysolutions.net/records/483/ajes-pharmaceuticals-llc/6619e0de-6689-4275-9d2c-76410ccbcb6b)
- [483 - 2022-11-21](https://www.globalkeysolutions.net/records/483/ajes-pharmaceuticals-llc/343bb849-0e6e-48ce-9d93-e55be6a74f82)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christopher-s-fields/066519e8-20eb-4c41-aaf6-5b17348a0409)

Company: https://www.globalkeysolutions.net/companies/ajes-pharmaceuticals-llc/4cf8708e-38cc-444a-84c3-5dde5f13721e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961