FDA Inspection 739733 — Abba Pharma, Inc
The FDA completed an inspection of Abba Pharma, Inc on August 26, 2011 in Tampa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 26, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |