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Delpharm Boucherville Canada Inc. FDA Inspection Record

FEI 3000280957 · Inspections, Form 483s, warning letters and import refusals

Delpharm Boucherville Canada Inc. is an FDA-registered facility (FEI 3000280957) located in Boucherville, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; REPACK; STERILIZE. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jan 26, 2024: Voluntary Action Indicated (VAI)
Inspections on record
7 (1 OAI, 3 VAI, 3 NAI)
Last OAI inspection
Aug 4, 2011
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
Jan 26, 2024Voluntary Action Indicated (VAI)Defined areas of adequate size for operations (21 CFR 211.42(c))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
Validation lacking for sterile drug products (21 CFR 211.113(b))
Feb 11, 2020No Action Indicated (NAI)No citations listed
Jun 12, 2018No Action Indicated (NAI)No citations listed
Aug 9, 2016No Action Indicated (NAI)No citations listed
Oct 22, 2013Voluntary Action Indicated (VAI)Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Procedures for sterile drug products (21 CFR 211.113(b))
Extent of discrepancy, failure investigations (21 CFR 211.192)
Scientifically sound laboratory controls (21 CFR 211.160(b))
and 2 more
Aug 4, 2011Official Action Indicated (OAI)No citations listed
Jul 15, 2009Voluntary Action Indicated (VAI)No citations listed

FDA record score

4 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 14, 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 VAIJan 26, 20246 x 0.63.6
Inspection classified VAIOct 22, 201310 years or older, so it adds no points0
Inspection classified OAIAug 4, 201110 years or older, so it adds no points0
Inspection classified VAIJul 15, 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 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 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 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Delpharm Boucherville Canada, Inc.
Location
Boucherville (CA)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; REPACK; STERILIZE
Source
decrs

Import refusals

FDA data resources

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