FDA Inspection
WSM Investments LLCWSM Investments LLC – FDA Inspection, Feb 12, 2014
Record Details
This FDA Inspection record concerns WSM Investments LLC, with an inspection on February 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- WSM Investments LLC
- Inspection Date
- February 12, 2014
- Product Type
- Devices
View Company Profile
ID · d32497ff-fd9d-413d-8100-56626a206296
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867536
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Showing 10 of 11 citations.
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Other FDA inspections of WSM Investments LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2019 | Not classified | Los Angeles District Office | |
| July 19, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for WSM Investments LLC
- FDA Inspection 1082154 - 2019-01-23
- FDA Inspection 735353 - 2011-07-19
- FDA Inspection 657997 - 2010-04-20
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