FDA Inspection 770816 — Midmark Corporation
The FDA completed an inspection of Midmark Corporation on March 13, 2012 in Buffalo Grove, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 13, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Buffalo Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5598 | 21 CFR 1020.30(e) | Word "model" or "type" permanent and legible |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |