FDA Inspection 1152207 — Karl Storz Endovision, Inc.
The FDA completed an inspection of Karl Storz Endovision, Inc. on September 17, 2021 in Charlton, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 17, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |