FDA Inspection 1145660 — Leadiant Biosciences, Inc.
The FDA completed an inspection of Leadiant Biosciences, Inc. on July 8, 2021 in Gaithersburg, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 8, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Gaithersburg, MD (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6830 | 21 CFR 314.80(c)(2) | Interval |