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Pralus Sas — FDA Facility Profile

FEI 3007646095

Pralus Sas is an FDA-inspected facility (FEI 3007646095) located in Roanne, FR. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Feb 28, 2020: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Feb 16, 2016
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
Feb 28, 2020No Action Indicated (NAI)No citations listed
Feb 16, 2016Official Action Indicated (OAI)Precluding contaminants (21 CFR 110.40(a))
Q.C. instrument accuracy, maintenance (21 CFR 110.40(f))
Sufficient space (21 CFR 110.20(b)(1))
Screening (21 CFR 110.20(b)(7))
and 7 more

Facility details

Company
Pralus Sas
Location
Roanne (FR)
Source
inspections

FDA data resources

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