FDA Inspection 662818 — Plexus Manufacturing Sdn. Bhd.
The FDA completed an inspection of Plexus Manufacturing Sdn. Bhd. on May 7, 2010 in Bayan Lepas. 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
- May 7, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bayan Lepas (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |