FDA Inspection
Acuity Polymers, Inc.Acuity Polymers, Inc. – FDA Inspection, Oct 9, 2018
Record Details
This FDA Inspection record concerns Acuity Polymers, Inc., with an inspection on October 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ca3bf203-d562-47a3-8f39-33f14c63cbd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068521
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Acuity Polymers, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2025 | Not classified | New York District Office | |
| August 3, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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