985027
Wei Laboratories, Inc. — FEI 3005717476
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 9, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 15538 | 21 CFR 111.255(d) | Batch record - readily available |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15555 | 21 CFR 111.260(j)(2)(iii) | Batch record - initials; component |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15950 | 21 CFR 111.110(b) | Quality control operations - tests, examinations |