FDA Inspection
Apothecary Products, Inc.Apothecary Products, Inc. – FDA Inspection, Jun 1, 2009
Record Details
This FDA Inspection record concerns Apothecary Products, Inc., with an inspection on June 1, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Apothecary Products, Inc.
- Inspection Date
- June 1, 2009
- Product Type
- Devices
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ID · dcf30f2e-eeb6-4f15-8bda-bc0292cf267d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 587465
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Apothecary Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 9, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 30, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Apothecary Products, Inc.
- FDA Inspection 859035 - 2013-12-18
- FDA Inspection 680873 - 2010-09-09
- FDA Inspection 617607 - 2009-09-30
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