# FDA 483 - PETNET Solutions, Inc. - July 09, 2021

Source: https://www.globalkeysolutions.net/records/483/petnet-solutions-inc/a06d808b-13a4-4bb0-ac15-4e9352c4be2d

> FDA 483 for PETNET Solutions, Inc. on July 09, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2021-07-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: PETNET Solutions, Inc. in Albany, NY, a pharmaceutical PET drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to implement appropriate corrective and preventative actions for out-of-specification results, instead invalidating initial OOS results and releasing affected batches. Additionally, the inspection revealed inadequate validation of laboratory analytical methods and a lack of procedures to ensure equipment suitability for its intended purpose, potentially affecting the quality of PET drugs.

## Related Documents

- [483 - 2026-01-09](https://www.globalkeysolutions.net/records/483/petnet-solutions-inc/43f73caa-d0bd-4fcb-bacd-40ef49000b73)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.globalkeysolutions.net/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.globalkeysolutions.net/companies/petnet-solutions-inc/6fc538c9-642d-4cd3-8591-e4b4d7e24238

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961