# FDA 483 - Acuity Polymers, Inc. - August 03, 2022

Source: https://www.globalkeysolutions.net/records/483/acuity-polymers-inc/b899d254-f8d6-4ee2-92f7-104713409cc3

> FDA 483 for Acuity Polymers, Inc. on August 03, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acuity Polymers, Inc.
- Inspection Date: 2022-08-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Acuity Polymers, Inc., a medical device manufacturer in Rochester, NY, was cited with four observations during an FDA inspection from August 1-3, 2022. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for corrective and preventive actions, complaint handling, and software validation. Additionally, personnel training records were not properly documented, indicating a moderate level of non-compliance with quality system regulations.

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/acuity-polymers-inc/91e80935-9f5b-43d5-a008-d4095aff0ce4

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