FDA Inspection 574552 — Suretex, Ltd.
The FDA completed an inspection of Suretex, Ltd. on February 19, 2009 in Surat-Thani. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Surat-Thani (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |