FDA Inspection
Pleasure Latex Products SDN BHDPleasure Latex Products SDN BHD – FDA Inspection, Apr 28, 2016
Record Details
This FDA Inspection record concerns Pleasure Latex Products SDN BHD, with an inspection on April 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 28, 2016
- Product Type
- Devices
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ID · 283fff9e-d876-4149-87ca-3f35e4a215bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 975498
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Pleasure Latex Products SDN BHD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pleasure Latex Products SDN BHD
- FDA Inspection 1180886 - 2022-09-08
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