FDA Inspection 975498 — Pleasure Latex Products SDN BHD
The FDA completed an inspection of Pleasure Latex Products SDN BHD on Apr 28, 2016 in Jeram. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Jeram (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |