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FDA establishment 3013488109, Sunnyvale, California, United States. Part of Algomedica'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: Mar 28, 2024
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 820.20(b)(3). Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
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 820.22. Quality Audits - defined intervals Quality audits were not performed at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
21 CFR 820.170(b). Installer records The person installing the device did not document the inspection and test results to demonstrate proper installation.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established.
21 CFR 820.30(e). Design review - Lack of or inadequate procedures Procedures for design review have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been 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
Sunnyvale, California, United States. Part of