Laboratoire Du-Var Inc — FDA Facility Profile

FEI 3002449500

Laboratoire Du-Var Inc is an FDA-registered facility (FEI 3002449500) located in Boucherville, CA. Registered operations: MANUFACTURE. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Oct 20, 2023: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
Last OAI inspection
None on record
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
Oct 20, 2023Voluntary Action Indicated (VAI)Approve or reject components, products (21 CFR 211.22(a))
Absence of Written Procedures (21 CFR 211.100(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Written procedures fail to include (21 CFR 211.67(b))
Jul 20, 2017Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Absence of Written Procedures (21 CFR 211.100(a))
Written procedures fail to include (21 CFR 211.67(b))

Facility details

Company
Laboratoire Du-Var Inc.
Location
Boucherville (CA)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE
Source
decrs

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