FDA Inspection 709156 — Innolatex Sdn. Bhd.
The FDA completed an inspection of Innolatex Sdn. Bhd. on Jan 20, 2011 in Port Klang. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 20, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Port Klang (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |