# FDA 483 - Avista Pharma Solutions, Inc. dba Cambrex - September 27, 2013

Source: https://www.keypedia.com/records/483/avista-pharma-solutions-inc-dba-cambrex/9f9dbbb7-e4b8-44a3-81c1-7d55709ef9c2

> FDA 483 for Avista Pharma Solutions, Inc. dba Cambrex on September 27, 2013. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avista Pharma Solutions, Inc. dba Cambrex
- Inspection Date: 2013-09-27
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: Microtest Laboratories, Inc. in Agawam, MA, was inspected by the FDA from September 16-27, 2013, and received eight observations. The inspection revealed significant deficiencies in quality control, aseptic processing, environmental monitoring, and validation of sterile drug product manufacturing. Key issues include releasing sterile injectable products without complete testing, inadequate smoke studies, and failures in investigating discrepancies and validating sterilization processes.

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## Related Officers

- [Assuring that quality medicines are available to the American public](https://www.keypedia.com/people/maya-m-davis/4180239e-5b21-4f9c-9ff0-6bbe5222f740)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94