FDA Inspection
Pro-Paks, LLCFDA Inspection 725186 - Pro-Paks, LLC - May 31, 2011
Record Details
This FDA Inspection record concerns Pro-Paks, LLC, with an inspection on May 31, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pro-Paks, LLC
- Inspection Date
- May 31, 2011
- Product Type
- Devices
View Company Profile
ID · 00bdbfda-7820-4e3b-b410-019563b73516
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 725186
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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Other FDA inspections of Pro-Paks, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pro-Paks, LLC
- FDA Inspection 768317 - 2012-02-03
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