FDA Inspection 1110713 — Spectra Baby USA
The FDA completed an inspection of Spectra Baby USA on November 22, 2019 in Davie, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |