1113332
Asept Pak Inc. — FEI 3007177643
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Malone, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |