# Avista Pharma Solutions, Inc. – FDA 483, Jul 25, 2025

Source: https://www.keypedia.com/records/483/avista-pharma-solutions-inc/dda545e9-7e67-4c8e-a7de-c638725bd84e

> FDA 483 for Avista Pharma Solutions, Inc. 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.
- 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 multiple deficiencies related to quality control, facility maintenance, and computer system controls. The inspection revealed failures to investigate environmental monitoring discrepancies, maintain clean and repaired facilities, adhere to quality unit procedures for environmental monitoring data approval, and implement adequate computer system access controls. These issues indicate significant concerns regarding the firm's adherence to cGMPs in its drug product sterility and endotoxin testing operations.

## Related Documents

- [EIR - 2025-07-25](https://www.keypedia.com/records/eir/avista-pharma-solutions-inc/a94e807f-a60a-40fd-b66f-102c3a957832) — date: July 25, 2025
- [EIR - 2019-12-18](https://www.keypedia.com/records/eir/avista-pharma-solutions-inc/d31551c3-16ba-4f4a-aaac-b85e5bf22bcc) — date: December 18, 2019
- [483 - 2013-09-27](https://www.keypedia.com/records/483/avista-pharma-solutions-inc/9f9dbbb7-e4b8-44a3-81c1-7d55709ef9c2) — date: September 27, 2013

## 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/abe58c04-c144-4601-a4df-a290928bafa5

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