FDA Inspection
ARP Manufacturing, LLCARP Manufacturing, LLC – FDA Inspection, Aug 29, 2019
Record Details
This FDA Inspection record concerns ARP Manufacturing, LLC, with an inspection on August 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8a39c2aa-8555-4264-bf13-fb91e4bf2c5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101458
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of ARP Manufacturing, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 28, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 28, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ARP Manufacturing, LLC
- FDA Inspection 951685 - 2015-10-16
- FDA Inspection 755862 - 2011-11-28
- FDA Inspection 559939 - 2009-01-28
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