FDA Inspection
Stone Company Management, Inc.Stone Company Management, Inc. – FDA Inspection, May 24, 2013
Record Details
This FDA Inspection record concerns Stone Company Management, Inc., with an inspection on May 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 24, 2013
- Product Type
- Devices
View Company Profile
ID · e60e4e3c-d186-4f53-b124-43088e3e1e45
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 833159
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stone Company Management, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 24, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Stone Company Management, Inc.
- FDA Inspection 1004167 - 2017-03-07
- FDA Inspection 897958 - 2014-09-24
- FDA Inspection 816869 - 2013-01-24
- FDA Inspection 654193 - 2010-03-11
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