FDA Inspection 1277871 — Femcap, Inc.
The FDA completed an inspection of Femcap, Inc. on Aug 8, 2025 in Warren, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 8, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Warren, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |