Company
MalaysiaPleasure Latex Products SDN BHD, Jeram, Malaysia – FDA Inspections
Inspection records and compliance data for Pleasure Latex Products SDN BHD in Jeram, -. 2 FDA inspections on record, last inspected September 08, 2022.
Company Profile
This profile covers Pleasure Latex Products SDN BHD based in Jeram, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 28, 2016. Last inspected September 8, 2022.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Equipment suitability & capability1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 8, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1180886 |
| April 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 975498 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Pleasure Latex Products SDN BHD
FEI Number
3009084570
Address
Jeram, - -, Malaysia
Country
Malaysia
ID: 41a5d89b-bf9e-46fb-9f3c-6b1912746272