483
Acuity Polymers, Inc.Acuity Polymers, Inc. – FDA 483, Aug 3, 2022
Record Details
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.
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ID · b899d254-f8d6-4ee2-92f7-104713409cc3
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