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FDA establishment 3021219789, Sunnyvale, California, United States. Part of Nimbleheart's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Jun 27, 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 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
21 CFR 820.70(g)(1). Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 820.50(a). Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by suppliers, contractors and consultants have not been established.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality have not been performed.
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(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.60. Identification procedures, Lack of or inadequate procedures Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been established.
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