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FDA establishment 3008167616, Dongguan, China. Part of Fudakang Industrial Co., Ltd.'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: Mar 12, 2026
Warning letters: 0
Import refusals 2014 to 2023: 1, first Oct 23, 2017
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.
02018Inspections0
020192019Inspections0vs 2018+0
02020Inspections0vs 2019+0
020212021Inspections0vs 2020+0
02022Inspections0vs 2021+0
020232023Inspections0vs 2022+0
12024Inspections1vs 2023+1
020252025Inspections0vs 2024−1
12026Inspections1vs 2025+1
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
ISO 13485:2016 Clause 8.3.1: Records of nonconforming product and actions taken not maintained1
ISO 13485:2016 Clause 8.3.1. Records of nonconforming product and actions taken not maintained Records of the nature of nonconforming product and any subsequent action taken, including the evaluation, and any investigation and the rationale for decisions, were not adequately maintained.
21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
ISO 13485:2016 Clause 4.1.4. Changes to the QMS not adequately controlled or evaluated Changes to quality management system processes were not controlled in accordance with requirements and evaluated for their impact on the quality management system and the medical devices produced.
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
Dongguan, China. Part of