FDA Inspection 932308 — Welch Allyn, Inc.
The FDA completed an inspection of Welch Allyn, Inc. on June 10, 2015 in Skaneateles Falls, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Skaneateles Falls, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |