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

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.