FDA Inspection 1203163 — Midwest Products and Engineering, Inc.
The FDA completed an inspection of Midwest Products and Engineering, Inc. on April 21, 2023 in Milwaukee, WI. 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
- April 21, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |