FDA Inspection
Percuvision LlcPercuvision Llc – FDA Inspection, Nov 16, 2016
Record Details
This FDA Inspection record concerns Percuvision Llc, with an inspection on November 16, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 99437c62-9e16-445f-86fa-15327263c255
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991427
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Percuvision Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Percuvision Llc
- FDA Inspection 671901 - 2010-07-14
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