FDA Inspection 812414 — American Ortho-Tech (P) Ltd.
The FDA completed an inspection of American Ortho-Tech (P) Ltd. on December 5, 2012 in Chennai, Tambaram. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 5, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chennai, Tambaram (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3149 | 21 CFR 820.180 | Availability |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |