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FDA establishment 1717855, Salt Lake City, Utah, United States. Part of Varex Imaging Corporation's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Aug 25, 2025
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 820.250(b). Sampling methods - Lack of or inadequate procedures Procedures to ensure sampling methods are adequate for their intended use have not been adequately established.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been adequately established.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.180(b). Retention period Required records are not retained for the design and expected life of the device and at least 2 years from the date of release of the device for commercial distribution.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately 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 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established and maintained.
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