FDA Inspection
Craftmatic Industries, Inc.Craftmatic Industries, Inc. – FDA Inspection, Apr 15, 2016
Record Details
This FDA Inspection record concerns Craftmatic Industries, Inc., with an inspection on April 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Craftmatic Industries, Inc.
- Inspection Date
- April 15, 2016
- Product Type
- Devices
View Company Profile
ID · 9275ae91-c684-4bbd-8806-eb5891b7c04b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966753
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Craftmatic Industries, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2023 | Not classified | Florida District Office | |
| March 7, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Craftmatic Industries, Inc.
- FDA Inspection 1203532 - 2023-04-17
- FDA Inspection 1164002 - 2022-03-07
- FDA Inspection 884702 - 2014-08-08
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