FDA Inspection
Sagami Manufacturers Sdn. Bhd.Sagami Manufacturers Sdn. Bhd. – FDA Inspection, Aug 5, 2010
Record Details
This FDA Inspection record concerns Sagami Manufacturers Sdn. Bhd., with an inspection on August 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 5, 2010
- Product Type
- Devices
View Company Profile
ID · d31c219a-d730-4ed4-8c04-8fe7d5e6a924
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 677350
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Sagami Manufacturers Sdn. Bhd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 6, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sagami Manufacturers Sdn. Bhd.
- FDA Inspection 935786 - 2015-07-02
- FDA Inspection 734630 - 2011-07-06
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