FDA Inspection 1217245 — Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.
The FDA completed an inspection of Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. on September 8, 2023 in Bangplee. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bangplee (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |