FDA Inspection 590063 — Bausch & Lomb Incorporated
The FDA completed an inspection of Bausch & Lomb Incorporated on May 12, 2009 in Greenville, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Greenville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3355 | 21 CFR 820.198(f) | Records accessibility |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |