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FDA establishment 3006979678, Qinhuangdao, China. Part of Contec Medical Systems Co., Ltd.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, its recalls since 2016, and the shipments FDA refused at the border.
Inspections: 4
Official action indicated: 1
Last inspection ended: Jun 12, 2025
Warning letters: 1
Recalls since 2016: 1
Import refusals since 2024: 18
Import refusals 2014 to 2023: 17, first Jan 21, 2014
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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
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.
21 CFR 820.180. Availability Required records are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA.
21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
21 CFR 820.70(a). Production processes Production processes were not conducted, controlled, and monitored to ensure that a device conforms to its specifications.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with.
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.
21 CFR 820.40(b). Document change records, maintained. Records of changes to documents were not adequately maintained.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Qinhuangdao, China. Part of