FDA Inspection 801398 — Abba Pharma, Inc
The FDA completed an inspection of Abba Pharma, Inc on September 21, 2012 in Tampa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 21, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15677 | 21 CFR 111.315(b)(1) | Sampling plans; components |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |