Company
MalaysiaSagami Manufacturers Sdn. Bhd., Batu Gajah, Malaysia – FDA Inspections
Inspection records and compliance data for Sagami Manufacturers Sdn. Bhd. in Batu Gajah. 3 FDA inspections on record (1 OAI), last inspected July 02, 2015.
Company Profile
This profile covers Sagami Manufacturers Sdn. Bhd. based in Batu Gajah, Malaysia.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 5, 2010. Last inspected July 2, 2015.
Most cited issue areas
- Design history file1 inspection
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 2, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 935786 |
| July 6, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 734630 |
| August 5, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 677350 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sagami Manufacturers Sdn. Bhd.
FEI Number
3005664717
Address
Plot 29, Lorong Bemban 4, Jalan Bemban, Batu Gajah, Malaysia
Country
Malaysia
ID: 286b1f92-9fe6-4f45-8f87-fbeeb9d537d2