FDA Inspection 1335940 — M.A.C. Medical Inc.
The FDA completed an inspection of M.A.C. Medical Inc. on Sep 16, 2026 in Millstadt, IL. 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
- Sep 16, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Millstadt, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23192 | ISO 13485:2016 Clause 7.6 | Monitoring and measurement requirements not determined |
| 23230 | ISO 13485:2016 Clause 8.2.6 | Monitoring and measurement requirements of product characteristics are not met |