Zhuhai United Laboratories Co. Ltd.

FDA Regulatory Profile

Zhuhai United Laboratories Co. Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 3, 2023 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 3, 2023Zhuhai, ChinaDrugsOfficial Action Indicated (OAI)3006531950
Jul 16, 2019Zhuhai, ChinaDrugsOfficial Action Indicated (OAI)3006531950
Sep 15, 2017Zhuhai, ChinaDrugsOfficial Action Indicated (OAI)3006531950
Mar 31, 2015Zhuhai, ChinaDrugsOfficial Action Indicated (OAI)3006531950
Oct 23, 2012Zhuhai, ChinaDrugsNo Action Indicated (NAI)3006531950
Sep 3, 2009Zhuhai, ChinaDrugsNo Action Indicated (NAI)3006531950

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3006531950Zhuhai, China6Aug 3, 2023

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.