FDA Inspection 1093439 — Karl Storz Endoscopy America Inc
The FDA completed an inspection of Karl Storz Endoscopy America Inc on June 4, 2019 in Auburn, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 4, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Auburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |