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FDA establishment 3010402752, Baoan District, China. Part of Hong Qiangxing (Shenzhen) Electronics Limited's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 2
Official action indicated: 1
Last inspection ended: Aug 7, 2025
Warning letters: 0
Import refusals since 2024: 4
Import refusals 2014 to 2023: 10, first May 1, 2015
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 820.30(j). Design history file The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 820.30(g). Design validation - software validation not performed Validation of device software is inadequate.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
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 adequately established.
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 adequately established.
Official Action Indicated (OAI)
Jul 14, 2016
Devices · Compliance: Devices
None posted
Voluntary Action Indicated (VAI)
Import Refusals
4 refused shipment lines since 2024, grouped by product and charges
STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONINGDevices · 89NGX
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
Baoan District, China. Part of