FDA Inspection
Rush Pin LLCRush Pin LLC – FDA Inspection, Aug 27, 2009
Record Details
This FDA Inspection record concerns Rush Pin LLC, with an inspection on August 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rush Pin LLC
- Inspection Date
- August 27, 2009
- Product Type
- Devices
View Company Profile
ID · 9581b6c9-493a-4b52-b49a-a62ca9b9e7b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 607047
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(e)(1)Activities performed
- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Rush Pin LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 28, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rush Pin LLC
- FDA Inspection 915531 - 2015-02-26
- FDA Inspection 774758 - 2012-03-28
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