FDA Inspection
Sgarlato Med, LLCSgarlato Med, LLC – FDA Inspection, Dec 29, 2010
Record Details
This FDA Inspection record concerns Sgarlato Med, LLC, with an inspection on December 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sgarlato Med, LLC
- Inspection Date
- December 29, 2010
- Product Type
- Devices
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ID · 672c5aef-1dbe-4c1b-a3e1-3bc51ce95e88
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697188
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.80(e)Documentation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 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(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.250(b)Sampling plans
Showing 10 of 11 citations.
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Other FDA inspections of Sgarlato Med, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sgarlato Med, LLC
- FDA Inspection 907533 - 2014-12-19
- FDA Inspection 660118 - 2010-04-05
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