JAZZ IMAGING — FDA Facility Profile
JAZZ IMAGING is an FDA-registered facility (FEI 3013503781) located in San Jose, CA, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 1, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (3 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 1, 2026 | Voluntary Action Indicated (VAI) | Process(es) for personnel competence, training and awareness not documented (ISO 13485:2016 Clause 6.2) Production controls not adequate (ISO 13485:2016 Clause 7.5.1) Complaint handling procedures lack required elements (ISO 13485:2016 Clause 8.2.2) Records of complaint investigations do not include required information (21 CFR 820.35(a)) and 1 more |
| Oct 24, 2022 | Voluntary Action Indicated (VAI) | Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Documentation (21 CFR 820.75(a)) Nonconforming product control (21 CFR 820.90(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 9 more |
| Jul 26, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Rationale documented for no investigation (21 CFR 820.198(b)) Remedial action (21 CFR 820.72(b)) Product rework procedures, Lack of or inadequate procedures (21 CFR 820.90(b)(2)) and 6 more |
Facility details
- Company
- Jazz Imaging
- Location
- San Jose, CA (US)
- Source
- device