FDA Inspection 812405 — Aurolab Trust
The FDA completed an inspection of Aurolab Trust on December 13, 2012 in Madurai. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 13, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Madurai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |