FDA Inspection 610286 — Gibson Laboratories, LLC
The FDA completed an inspection of Gibson Laboratories, LLC on September 14, 2009 in Lexington, KY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 14, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |