FDA Inspection 1235858 — OSI SYSTEMS PVT LTD(OPTOELECTRONICS DIVISION)
The FDA completed an inspection of OSI SYSTEMS PVT LTD(OPTOELECTRONICS DIVISION) on Mar 21, 2024 in Hyderabad. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |