FDA Inspection 1200973 — Janssen Ortho LLC
The FDA completed an inspection of Janssen Ortho LLC on March 28, 2023 in Gurabo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gurabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |