FDA Inspection 1224945 — Eurolatex Sdn.Bhd.
The FDA completed an inspection of Eurolatex Sdn.Bhd. on Nov 30, 2023 in Kuala Ketil. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 30, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kuala Ketil (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3837 | 21 CFR 820.25(b) | Training records |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |