727476
Tarmac Products, Inc. — FEI 1025483
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 2, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami Gardens, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15781 | 21 CFR 111.415 | Fill, assemble, package, label - quality |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4414 | 21 CFR 211.204 | Record information maintained |