FDA Inspection 636134 — Headstar Medical Products Co., Ltd.
The FDA completed an inspection of Headstar Medical Products Co., Ltd. on November 5, 2009 in New Taipei City. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Taipei City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |