FDA Inspection 1155123 — Syntron Bioresearch Inc
The FDA completed an inspection of Syntron Bioresearch Inc on Oct 14, 2021 in Carlsbad, CA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 14, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3149 | 21 CFR 820.180 | Availability |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |