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Jalco Cosmetics Pty Ltd. — FDA Facility Profile

FEI 3003906415

Jalco Cosmetics Pty Ltd. is an FDA-inspected facility (FEI 3003906415) located in Hornsby, AU. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Dec 13, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Dec 13, 2017
Warning letters
1 listed by FDA for this FEI, latest May 18, 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
Dec 13, 2017Official Action Indicated (OAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Written procedures not established/followed (21 CFR 211.67(b))
Computer control of master formula records (21 CFR 211.68(b))
Absence of Written Procedures (21 CFR 211.100(a))
and 5 more

Facility details

Company
Jalco Cosmetics Pty Ltd.
Location
Hornsby (AU)
Source
inspections

Compliance actions

FDA data resources

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