FDA Inspection
Post Medical, Inc.Post Medical, Inc. – FDA Inspection, Mar 23, 2010
Record Details
This FDA Inspection record concerns Post Medical, Inc., with an inspection on March 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Post Medical, Inc.
- Inspection Date
- March 23, 2010
- Product Type
- Devices
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ID · 6baf48dc-1973-4ccb-9f1c-ac7240f0dfe7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653219
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.25(b)Training
- 21 CFR 820.25(a)Sufficient personnel
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.100(a)(3)Identifying corrective & preventive actions
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Post Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Post Medical, Inc.
- FDA Inspection 923896 - 2015-04-20
- FDA Inspection 813074 - 2012-12-16
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