FDA Inspection 768467 — Bausch Health Americas, Inc.
The FDA completed an inspection of Bausch Health Americas, Inc. on Feb 10, 2012 in Petaluma, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 10, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Petaluma, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |