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Delta Laboratories Pty Ltd — FDA Facility Profile

FEI 3004085558

Delta Laboratories Pty Ltd is an FDA-inspected facility (FEI 3004085558) located in Somersby, 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
Mar 31, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Mar 31, 2017
Warning letters
1 listed by FDA for this FEI, latest Dec 19, 2017
Import refusals
2

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
Mar 31, 2017Official Action Indicated (OAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Written procedures not established/followed (21 CFR 211.67(b))
Absence of Written Procedures (21 CFR 211.100(a))
Component addition checked by 2nd person (21 CFR 211.101(d))
and 9 more

Facility details

Company
Delta Laboratories Pty Ltd
Location
Somersby (AU)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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