FDA Inspection
Acuderm, Inc.Acuderm, Inc. – FDA Inspection, May 9, 2014
Record Details
This FDA Inspection record concerns Acuderm, Inc., with an inspection on May 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Acuderm, Inc.
- Inspection Date
- May 9, 2014
- Product Type
- Devices
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ID · fc45bf3e-8f2e-4760-89f4-6e6307c32c6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 878759
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - Lack of or inadequate 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 |
|---|---|---|---|
| July 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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