FDA Inspection 781826 — BL Industria Otica, Ltda.
The FDA completed an inspection of BL Industria Otica, Ltda. on Apr 5, 2012 in Porto Alegre. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 5, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Porto Alegre (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |