FDA Inspection
Healthmark Industries Co., Inc.Healthmark Industries Co., Inc. – FDA Inspection, Dec 11, 2009
Record Details
This FDA Inspection record concerns Healthmark Industries Co., Inc., with an inspection on December 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 11, 2009
- Product Type
- Devices
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ID · eef5da59-0164-4398-9ace-24a047426172
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635306
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Healthmark Industries Co., Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Healthmark Industries Co., Inc.
- FDA Inspection 830355 - 2013-04-26
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