Company
SingaporeBIOPTIMAL INTERNATIONAL PTE. LTD., Singapore, Singapore – FDA Inspections
Inspection records and compliance data for BIOPTIMAL INTERNATIONAL PTE. LTD. in Singapore. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected November 09, 2023.
Company Profile
This profile covers BIOPTIMAL INTERNATIONAL PTE. LTD. based in Singapore, Singapore.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 9, 2023.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2023 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1222563 |
FDA documents
Form 483s (1)
People (2)
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Company Information
Name
BIOPTIMAL INTERNATIONAL PTE. LTD.
FEI Number
3016261803
Address
36 Jalan Tukang, Singapore, Singapore
Country
Singapore
ID: 8881d933-c435-47dd-8154-61e02c7c708b