930190
Bausch Health Americas, Inc. — FEI 3009443653
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 28, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1924 | 21 CFR 211.166(a)(5) | Testing of reconstituted drugs |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |