# FDA 483 - Cosette Pharmaceuticals NC Laboratories, LLC - July 21, 2023

Source: https://www.keypedia.com/records/483/cosette-pharmaceuticals-nc-laboratories-llc/a201478d-51ec-44bc-ae66-df943b769f1a

> FDA 483 for Cosette Pharmaceuticals NC Laboratories, LLC on July 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosette Pharmaceuticals NC Laboratories, LLC
- Inspection Date: 2023-07-21
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Cosette Pharmaceuticals NC Laboratories, LLC in Lincolnton, NC, revealed significant deficiencies in their receiving warehouse operations. Observations included inadequate separation of raw materials leading to potential cross-contamination and failure to follow written procedures for handling damaged components. These issues indicate a lack of control over material handling and storage, posing risks to drug product quality.

## Related Officers

- [ CSO](https://www.keypedia.com/people/megan-t-ziegler/3e83a317-701a-4e40-bb43-34d294d3448f)
- [issuing_officer](https://www.keypedia.com/people/harshal-j-desai/9ccefb1f-95fc-4a17-9647-eecb5c3ce838)
- [Investigator](https://www.keypedia.com/people/regan-t-harp/f27e8e4f-2a75-4c4b-8c3e-f8f8ca0717f3)

Company: https://www.keypedia.com/companies/cosette-pharmaceuticals-nc-laboratories-llc/4f90e360-99ea-4457-a022-4950a8ea7644

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7