FDA Inspection 678329 — Abba Pharma, Inc
The FDA completed an inspection of Abba Pharma, Inc on August 30, 2010 in Tampa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 30, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- 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 |