FDA Inspection 1302466 — BBS Enterprises
The FDA completed an inspection of BBS Enterprises on February 4, 2026 in Mishawaka, IN. 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
- February 4, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mishawaka, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23091 | ISO 13485:2016 Clause 7.2.1 | Requirements related to product not determined |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |