FDA Inspection 1320108 — Bioplate Inc
The FDA completed an inspection of Bioplate Inc on June 1, 2026 in Placentia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Placentia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23086 | ISO 13485:2016 Clause 7.1 | Planning of product realization not consistent with other QMS processes |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23212 | ISO 13485:2016 Clause 8.2.1 | Feedback process procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |