# FDA 483 - AJES Pharmaceuticals, LLC - November 21, 2022

Source: https://www.keypedia.com/records/483/ajes-pharmaceuticals-llc/343bb849-0e6e-48ce-9d93-e55be6a74f82

> FDA 483 for AJES Pharmaceuticals, LLC on November 21, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AJES Pharmaceuticals, LLC
- Inspection Date: 2022-11-21
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: AJES Pharmaceuticals, LLC, a dietary supplement manufacturer in Copiague, NY, received a Form 483 with five observations, including repeat findings. The inspection revealed significant deficiencies in finished product testing, laboratory controls for reference standards, equipment cleaning and maintenance, and record-keeping for master and batch manufacturing. These issues indicate a lack of adequate quality control and adherence to good manufacturing practices.

## Related Documents

- [483 - 2018-03-29](https://www.keypedia.com/records/483/ajes-pharmaceuticals-llc/6619e0de-6689-4275-9d2c-76410ccbcb6b)
- [483 - 2021-10-14](https://www.keypedia.com/records/483/ajes-pharmaceuticals-llc/87ce17f9-36ed-4d68-90a8-40f1a38d6ba8)

## Related Officers

- [Erica Raphael](https://www.keypedia.com/people/erica-raphael/f215b49b-e1ba-42a0-9fd0-d8899dca9ddd)

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

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