# FDA 483 - Amneal Pharmaceuticals of New York, LLC - March 18, 2019

Source: https://www.keypedia.com/records/483/amneal-pharmaceuticals-of-new-york-llc/0a34426e-a08e-4d2a-a71a-182146fa7281

> FDA 483 for Amneal Pharmaceuticals of New York, LLC on March 18, 2019. 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: 2019-03-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Amneal Pharmaceuticals of New York, LLC in Hauppauge, NY, was inspected by the FDA from March 5-18, 2019, and received one observation. The inspection revealed a significant issue with inadequate humidity control in the warehouse, affecting the storage conditions of empty hard gelatin capsules used in drug manufacturing. This deficiency could compromise the identity, strength, quality, and purity of drug products.

## Related Officers

- [Consumer Safety Officer at FDA](https://www.keypedia.com/people/alice-s-tsao/b6d72ceb-de7c-413d-b104-cac3b075c170)

Company: https://www.keypedia.com/companies/amneal-pharmaceuticals-of-new-york-llc/5fccf191-b139-4eb8-98a1-7e6954253cd1

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