FDA Inspection
Acuderm, Inc.Acuderm, Inc. – FDA Inspection, Jul 13, 2017
Record Details
This FDA Inspection record concerns Acuderm, Inc., with an inspection on July 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b8ae7ad1-3de0-4869-91dd-36d573b6b2fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017933
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Acuderm, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 19, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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