FDA Inspection 668387 — Aspire Pharmaceuticals, Inc.
The FDA completed an inspection of Aspire Pharmaceuticals, Inc. on June 21, 2010 in Somerset, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 21, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16008 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |