FDA Inspection
Acumed LLCAcumed LLC – FDA Inspection, May 11, 2017
Record Details
This FDA Inspection record concerns Acumed LLC, with an inspection on May 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f669411c-a4f0-4bde-a9a5-3c7611afbbb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015903
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Acumed LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 27, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Acumed LLC
- FDA Inspection 838475 - 2013-06-26
- FDA Inspection 736552 - 2011-07-27
- FDA Inspection 606927 - 2009-08-25
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