FDA Inspection 1301828 — Aspire Pharmaceuticals, Inc.
The FDA completed an inspection of Aspire Pharmaceuticals, Inc. on April 24, 2026 in Somerset, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |