FDA Inspection 987439 — Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.
The FDA completed an inspection of Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. on September 9, 2016 in Bangplee. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 9, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bangplee (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4347 | 21 CFR 211.160(b)(2) | In process materials - conformance to written specs |