FDA Inspection 1333866 — Beacon Bio Dx LLC
The FDA completed an inspection of Beacon Bio Dx LLC on Sep 1, 2026 in Cleveland, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23107 | ISO 13485:2016 Clause 7.3.4 | Design and development outputs not adequate |
| 23135 | ISO 13485:2016 Clause 7.3.9 | Records of design and development changes and their reviews not maintained |
| 23143 | ISO 13485:2016 Clause 7.4.1 | Results of supplier monitoring not used as input into the supplier re-evaluation |