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Apotex Pharmachem India Pvt. Ltd. FDA Inspection Record

FEI 3005466325 · Inspections, Form 483s, warning letters and import refusals

Apotex Pharmachem India Pvt. Ltd. is an FDA-registered facility (FEI 3005466325) located in Karnataka 560 099, IN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Mar 14, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (1 OAI, 5 VAI, 1 NAI)
Last OAI inspection
Jan 31, 2014
Warning letters
1 listed by FDA for this FEI, latest Jun 16, 2014
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
Mar 14, 2025Voluntary Action Indicated (VAI)No citations listed
Sep 2, 2022No Action Indicated (NAI)No citations listed
Jan 31, 2020Voluntary Action Indicated (VAI)No citations listed
Jun 26, 2018Voluntary Action Indicated (VAI)No citations listed
Jun 3, 2016Voluntary Action Indicated (VAI)No citations listed
Jan 31, 2014Official Action Indicated (OAI)No citations listed
Dec 1, 2010Voluntary Action Indicated (VAI)No citations listed

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
Apotex Pharmachem India Pvt Ltd.
Location
Karnataka 560 099 (IN)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; 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.