FDA Inspection 1195306 — Acrotech Biopharma Inc.
The FDA completed an inspection of Acrotech Biopharma Inc. on Jan 19, 2023 in East Windsor, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 19, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- East Windsor, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6735 | 21 CFR 314.80(c)(1)(ii) | Failure to investigate serious, unexpected events |
| 6835 | 21 CFR 314.80(d) | Failure to submit scientific article |