FDA Inspection 1111849 — Medicrea USA Corp
The FDA completed an inspection of Medicrea USA Corp on November 21, 2019 in New York, NY. 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 21, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 537 | 21 CFR 820.70(a) | Production processes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |