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BR SAS — FDA Facility Profile

FEI 1000373305

BR SAS is an FDA-inspected facility (FEI 1000373305) located in Suresnes, FR. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Sep 22, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Sep 22, 2017
Warning letters
1 listed by FDA for this FEI, latest Jun 8, 2018
Import refusals
3

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
Sep 22, 2017Official Action Indicated (OAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Training--operations, GMPs, written procedures (21 CFR 211.25(a))
Testing and release for distribution (21 CFR 211.165(a))
Lack of written stability program (21 CFR 211.166(a))
and 6 more

Facility details

Company
BR SAS
Location
Suresnes (FR)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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