# FDA 483 - AJES Pharmaceuticals, LLC - March 29, 2018

Source: https://www.globalkeysolutions.net/records/483/ajes-pharmaceuticals-llc/6619e0de-6689-4275-9d2c-76410ccbcb6b

> FDA 483 for AJES Pharmaceuticals, LLC on March 29, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AJES Pharmaceuticals, LLC
- Inspection Date: 2018-03-29
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of AJES Pharmaceuticals LLC in Copiague, NY, a dietary supplement manufacturer, revealed significant deficiencies in quality control. The firm failed to adequately test finished dietary supplements for identity, purity, strength, and composition, and did not establish proper identity specifications for components. These issues, including a repeat observation, indicate a lack of scientific rationale and documentation for ensuring product quality.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/meredith-p-soehl/52252b59-8f03-41e4-a86f-b92c98048023)

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