FDA Inspection 1338726 — Jazz Imaging
The FDA completed an inspection of Jazz Imaging on Oct 1, 2026 in San Jose, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 1, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23070 | ISO 13485:2016 Clause 6.2 | Process(es) for personnel competence, training and awareness not documented |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23265 | 21 CFR 820.35(a) | Records of complaint investigations do not include required information |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |