ATP Science Pty Ltd — FDA Facility Profile

FEI 3012380024

ATP Science Pty Ltd is an FDA-inspected facility (FEI 3012380024) located in Loganholme, AU. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 8, 2022: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Mar 10, 2020
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

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 8, 2022Voluntary Action Indicated (VAI)Batch record - date, time; maintenance (21 CFR 111.260(c))
Sampling plans; finished batches (21 CFR 111.315(b)(3))
Mar 10, 2020Official Action Indicated (OAI)Component - verify identity, dietary ingredient (21 CFR 111.75(a)(1)(i))
Component - qualify supplier (21 CFR 111.75(a)(2)(ii)(A))
Specifications met - verify; finished batch (21 CFR 111.75(c))
Quality control operations - batch production records (21 CFR 111.123(a)(2))
and 1 more

Facility details

Company
ATP Science Pty Ltd
Location
Loganholme (AU)
Source
inspections

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