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Luen Wah (HK) Medicine Ltd — FDA Facility Profile

FEI 3004962092

Luen Wah (HK) Medicine Ltd is an FDA-inspected facility (FEI 3004962092) located in Chai Wan. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Sep 28, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Sep 28, 2017
Warning letters
1 listed by FDA for this FEI, latest Apr 6, 2018

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 28, 2017Official Action Indicated (OAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Absence of Written Procedures (21 CFR 211.100(a))
Lack of written stability program (21 CFR 211.166(a))
and 5 more

Facility details

Company
Luen Wah (HK) Medicine Ltd
Location
Chai Wan
Source
inspections

Compliance actions

FDA data resources

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