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BJP Laboratories Pty Ltd — FDA Facility Profile

FEI 3013114384

BJP Laboratories Pty Ltd is an FDA-inspected facility (FEI 3013114384) located in Yatala, AU. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Mar 4, 2020: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Mar 4, 2020
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

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 4, 2020Official Action Indicated (OAI)Scheduled processes not established (21 CFR 113.83)
Examination, testing; scientifically valid (21 CFR 111.320(b))
Specifications-component purity, strength, composition (21 CFR 111.70(b)(2))
Specifications met - verify; finished batch (21 CFR 111.75(c))
and 2 more

Facility details

Company
BJP Laboratories Pty Ltd
Location
Yatala (AU)
Source
inspections

Import refusals

FDA data resources

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