1078694
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 8, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |