FDA Inspection 694902 — Laglove Sdn Bhd (M) aka LA Glove
The FDA completed an inspection of Laglove Sdn Bhd (M) aka LA Glove on September 9, 2010 in Kajang. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kajang (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |