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

Source: https://www.keypedia.com/records/483/avista-pharma-solutions-inc-dba-cambrex/9114de19-b62a-4740-b343-34d5774c7c21

> 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
- Summary: During an inspection conducted from July 22-25, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Cambrex Agawam, a control laboratory facility. This document details several observations indicating deviations from regulatory expectations, particularly concerning Good Manufacturing Practices. Key findings included a failure to thoroughly investigate unexplained discrepancies, specifically an environmental monitoring excursion in an ISO-6 cleanroom used for sterility testing. Inspectors also noted significant cleanliness and maintenance issues within critical processing areas, including red-brown streaking and rust-like residue on surfaces and equipment in ISO-6 and ISO-7 rooms, as well as paint chipping and liquid pooling with signs of corrosion in the utility area supporting cleanroom air handlers. Furthermore, the quality control unit at Cambrex Agawam was found not to be fully following its procedures, with a recurring failure to approve environmental monitoring certificates of analysis within established timelines. Critical gaps in data integrity were also identified, as laboratory analyst-level computer accounts lacked sufficient controls, allowing for the deletion of data from instruments used for endotoxin testing and modification of computer system time. These observations, issued under the Federal Food, Drug, and Cosmetic Act, highlight a need for Cambrex Agawam to implement robust corrective and preventive actions. The company is expected to address these findings to ensure the facility is maintained in a state of control, product quality is assured, and regulatory compliance is achieved.

## 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/887e62a3-6beb-4a60-b52c-33a782b5d2ca)
- [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