FDA Inspection 669164 — Bausch & Lomb Incorporated
The FDA completed an inspection of Bausch & Lomb Incorporated on June 25, 2010 in Greenville, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Greenville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |