Company
MalaysiaAmbu Sdn. Bhd., Penang, Malaysia – FDA Inspections
Inspection records and compliance data for Ambu Sdn. Bhd. in Penang. 3 FDA inspections on record, 1 Form 483, last inspected August 17, 2023.
Company Profile
This profile covers Ambu Sdn. Bhd. based in Penang, Malaysia.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 19, 2013. Last inspected August 17, 2023.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 17, 2023 | Not classified | Medical Devices & Rad Health | 1215014 |
| April 15, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 967208 |
| September 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 853156 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ambu Sdn. Bhd.
FEI Number
3004040397
Address
Lot 69-B, Lintang Bayan Lepas 6, Phase Iv, Penang, Malaysia
Country
Malaysia
ID: a878b745-cdde-4abf-9032-dddf266db7c0