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FDA establishment 3013503781, San Jose, California, United States. Part of Jazz Imaging, LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 0
Last inspection ended: Oct 1, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
ISO 13485:2016 Clause 8.2.2. Complaint handling procedures lack required elements Procedures for timely complaint handling do not adequately include requirements and responsibilities for determining the need to report the information to FDA.
ISO 13485:2016 Clause 6.2. Process(es) for personnel competence, training and awareness not documented Process(es) for providing needed training have not been documented.
21 CFR 820.35(a). Records of complaint investigations do not include required information Records of complaint investigations do not include any unique device identifier (UDI) or universal product code (UPC) and any other device identification(s).
ISO 13485:2016 Clause 7.5.1. Production controls not adequate Production controls do not include implementation of monitoring and measurement of process parameters and product characteristics.
21 CFR 820.50(a)(1). Documented evaluation The evaluation of potential suppliers and contractors was not documented.
21 CFR 820.70(g). Equipment Installation, Placement, Specified Requirements The equipment used in the manufacturing process does not meet specified requirements.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.198(e). Records of complaint investigation Records of complaint investigations do not include required information.
21 CFR 820.20(b)(3)(i). Management representative implementing the quality system The management representative has not ensured that the quality system requirements are effectively established and maintained.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.75(a). Documentation Process validation activities have not been documented and approved.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been established.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.250(a). Statistical techniques - Lack of or inadequate procedures Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been adequately established.
21 CFR 820.72(b). Remedial action When test/measurement equipment was found to not meet accuracy and precision limits, no action was taken to evaluate whether there was any adverse effect on the device's quality.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and implemented.
21 CFR 820.90(b)(2). Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been documented in the device history record.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits and reaudits have not been performed.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
21 CFR 820.90(b)(2). Product rework procedures, Lack of or inadequate procedures Procedures for rework of nonconforming product have not been established.
21 CFR 820.198(b). Rationale documented for no investigation Records for complaints where no investigation was made do not include required information.
21 CFR 820.50(a)(1). Documented evaluation The evaluation of potential suppliers, contractors and consultants was not documented.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
San Jose, California, United States. Part of