FDA Inspection 816869 — Stone Company Management, Inc.
The FDA completed an inspection of Stone Company Management, Inc. on January 24, 2013 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |