FDA Inspection 1230647 — Karl Storz Endoscopy America Inc
The FDA completed an inspection of Karl Storz Endoscopy America Inc on February 15, 2024 in Auburn, MA. 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
- February 15, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Auburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |