FDA Inspection 1342172 — Macbrud Corporation
The FDA completed an inspection of Macbrud Corporation on Oct 20, 2026 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 20, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23231 | ISO 13485:2016 Clause 8.2.6 | Evidence of conformity to the acceptance criteria not maintained |