FDA Inspection
Windstone Medical Packaging, Inc. dba AMSWindstone Medical Packaging, Inc. dba AMS – FDA Inspection, Nov 2, 2009
Record Details
This FDA Inspection record concerns Windstone Medical Packaging, Inc. dba AMS, with an inspection on November 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 2, 2009
- Product Type
- Devices
View Company Profile
ID · 00b5617c-2578-48f3-a7cd-12fd63f2c6a2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 626082
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Windstone Medical Packaging, Inc. dba AMS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Windstone Medical Packaging, Inc. dba AMS
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.