# FDA 483 - Amneal Pharmaceuticals of New York, LLC - June 07, 2023

Source: https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-of-new-york-llc/9e350a01-ab3c-4788-af71-61c7956f30e1

> FDA 483 for Amneal Pharmaceuticals of New York, LLC on June 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals of New York, LLC
- Inspection Date: 2023-06-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Amneal Pharmaceuticals of New York, LLC, a prescription and OTC drug manufacturer, received five observations during an FDA inspection. The firm was cited for failures in quality control, including inadequate investigation of out-of-specification results, lack of equipment qualification and calibration, and absence of proper cleaning procedures. These issues indicate significant deficiencies in the firm's quality systems and adherence to regulatory requirements.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/amneal-pharmaceuticals-of-new-york-llc/553a76ad-6ec4-4143-ae7b-5dbb1e46eb5c)

## Related Officers

- [Rital B Patel](https://www.globalkeysolutions.net/people/rital-b-patel/dfd20acf-0fe4-42d9-9aff-e33451f9e731)
- [Amatul H. Marium](https://www.globalkeysolutions.net/people/amatul-h-marium/5db400ce-ffde-4310-82f8-766fd2458a4d)
- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.globalkeysolutions.net/companies/amneal-pharmaceuticals-of-new-york-llc/fd9a56cf-8f99-4c9d-99b2-7bca86ec70eb

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