FDA Inspection
Laglove Sdn Bhd (M) aka LA GloveLaglove Sdn Bhd (M) aka LA Glove – FDA Inspection, Sep 9, 2010
Record Details
This FDA Inspection record concerns Laglove Sdn Bhd (M) aka LA Glove, with an inspection on September 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 9, 2010
- Product Type
- Devices
View Company Profile
ID · 8742f4df-bf95-4365-a391-8bf4b1aa0bd6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 694902
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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