FDA Inspection 881173 — Bausch Health US., LLC.
The FDA completed an inspection of Bausch Health US., LLC. on May 19, 2014 in Bridgewater, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 19, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bridgewater, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7557 | 21 CFR 312.56(b) | Notification of FDA of termination of investigator |