# FDA 483 - Amneal Pharmaceuticals, LLC - February 10, 2022

Source: https://www.keypedia.com/records/483/amneal-pharmaceuticals-llc/1c7d1f79-382c-41a7-9661-7cb95f860d68

> FDA 483 for Amneal Pharmaceuticals, LLC on February 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals, LLC
- Inspection Date: 2022-02-10
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Amneal Pharmaceuticals, LLC in Piscataway, NJ, received a Form 483 with two observations during an inspection from January 24 to February 10, 2022. The inspection revealed failures in following procedures to prevent microbiological contamination in drug products and a lack of qualification for equipment used in manufacturing commercial and ANDA stability batches. These issues indicate significant deficiencies in the firm's quality control and manufacturing processes.

## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)
- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.keypedia.com/companies/amneal-pharmaceuticals-llc/40df6978-669a-4898-b381-a43f7fb4d40a

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248