1151771
Seaway Pharma Inc. — FEI 3012275336
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 15, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Massena, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |