FDA Inspection
Craftmatic Industries, Inc.Craftmatic Industries, Inc. – FDA Inspection, Aug 8, 2014
Record Details
This FDA Inspection record concerns Craftmatic Industries, Inc., with an inspection on August 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Craftmatic Industries, Inc.
- Inspection Date
- August 8, 2014
- Product Type
- Devices
View Company Profile
ID · fccd04af-35cd-4f2b-9333-ace3a7b492f3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 884702
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 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 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR 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 |
| April 15, 2016 | VAI | 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 966753 - 2016-04-15
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