678329
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 30, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15482 | 21 CFR 111.23(c) | Records - water |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |