FDA Inspection
Crothall Laundry SystemsCrothall Laundry Systems – FDA Inspection, Nov 9, 2010
Record Details
This FDA Inspection record concerns Crothall Laundry Systems, with an inspection on November 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Crothall Laundry Systems
- Inspection Date
- November 9, 2010
- Product Type
- Devices
View Company Profile
ID · e38d384a-bf8f-41b6-ac6f-4b49b3b0cc3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699842
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Crothall Laundry Systems
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Crothall Laundry Systems
- FDA Inspection 837459 - 2013-06-24
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