FDA Inspection 1085079 — Flexicare, Inc.
The FDA completed an inspection of Flexicare, Inc. on April 4, 2019 in Ivyland, PA. 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
- April 4, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ivyland, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |