# FDA 483 - Pharmascience Inc. - February 13, 2024

Source: https://www.globalkeysolutions.net/records/483/pharmascience-inc/4a4d1800-cb5b-4bd1-84af-0d0f9f0ad86a

> FDA 483 for Pharmascience Inc. on February 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmascience Inc.
- Inspection Date: 2024-02-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Pharmascience Inc., a manufacturer of sterile and non-sterile drug products, revealed significant deficiencies in quality control processes. The firm failed to thoroughly investigate out-of-specification results and customer complaints, leading to the release of potentially non-conforming products. Additionally, procedures for preventing microbiological contamination of sterile products were inadequate, and the stability testing program was not followed.

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/pharmascience-inc/2fa6f1e7-a980-4d37-b8d0-daf9e3a309c4

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1