# FDA 483 - Avista Pharma Solutions, Inc. dba Cambrex - July 25, 2025

Source: https://www.keypedia.com/records/483/avista-pharma-solutions-inc-dba-cambrex/887e62a3-6beb-4a60-b52c-33a782b5d2ca

> FDA 483 for Avista Pharma Solutions, Inc. dba Cambrex on July 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avista Pharma Solutions, Inc. dba Cambrex
- Inspection Date: 2025-07-25
- Product Type: drugs
- Office Name: New England District Office
- Summary: Avista Pharma Solutions, Inc. in Agawam, MA, was inspected and cited for significant deficiencies in its control laboratory operations. Observations included failures to investigate environmental monitoring discrepancies, maintain clean and repaired facilities, adhere to quality unit procedures for data review, and implement adequate computer system controls for data integrity. These issues indicate a lack of robust quality systems and facility maintenance for drug product sterility and endotoxin testing.

## Related Documents

- [483 - 2013-09-27](https://www.keypedia.com/records/483/avista-pharma-solutions-inc-dba-cambrex/9f9dbbb7-e4b8-44a3-81c1-7d55709ef9c2)
- [483 - 2025-07-25](https://www.keypedia.com/records/483/avista-pharma-solutions-inc-dba-cambrex/9114de19-b62a-4740-b343-34d5774c7c21)
- [483 - 2025-07-25](https://www.keypedia.com/records/483/avista-pharma-solutions-inc-dba-cambrex/dda545e9-7e67-4c8e-a7de-c638725bd84e)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [investigator](https://www.keypedia.com/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)

Company: https://www.keypedia.com/companies/avista-pharma-solutions-inc-dba-cambrex/abe58c04-c144-4601-a4df-a290928bafa5

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144