1075781
Seaway Pharma Inc. — FEI 3012275336
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 10, 2018
- Fiscal Year
- 2019
- 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 |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |