FDA Inspection 1230106 — RB Health (US) LLC
The FDA completed an inspection of RB Health (US) LLC on Dec 20, 2024 in Parsippany, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Parsippany, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 18025 | 21 CFR 314.80(c)(2)(ii)(B) | Late submission of an ICSR |
| 6835 | 21 CFR 314.80(d) | Failure to submit scientific article |