FDA Inspection 1254656 — Shiseido America Inc.
The FDA completed an inspection of Shiseido America Inc. on Dec 3, 2024 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 3, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Windsor, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |