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ZACH SYSTEM S.A. FDA Inspection Record

FEI 3002808164 · Inspections, Form 483s, warning letters and import refusals

ZACH SYSTEM S.A. is an FDA-registered facility (FEI 3002808164) located in AVRILLE, FR. Registered operations: API MANUFACTURE. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Feb 12, 2021: Voluntary Action Indicated (VAI)
Inspections on record
5 (1 OAI, 2 VAI, 2 NAI)
Last OAI inspection
Jun 11, 2009
Warning letters
1 listed by FDA for this FEI, latest Oct 23, 2009
Import refusals
1

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 12, 2021Voluntary Action Indicated (VAI)No citations listed
Dec 7, 2017Voluntary Action Indicated (VAI)No citations listed
Oct 16, 2014No Action Indicated (NAI)No citations listed
Dec 2, 2010No Action Indicated (NAI)No citations listed
Jun 11, 2009Official Action Indicated (OAI)No citations listed

FDA record score

3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIFeb 12, 20216 x 0.251.5
Inspection classified VAIDec 7, 20176 x 0.251.5
Warning letter on FDA's dashboard, which does not show close-outsOct 23, 200910 years or older, so it adds no points0
Inspection classified OAIJun 11, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Zach System S.A.
Location
AVRILLE (FR)
Registration Expires
Dec 31, 2026
Operations
API MANUFACTURE
Source
decrs

Compliance actions

Import refusals

FDA data resources

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