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AMOL PHARMACEUTICALS PRIVATE LIMITED FDA Inspection Record

FEI 3003925108 · Inspections, Form 483s, warning letters and import refusals

AMOL PHARMACEUTICALS PRIVATE LIMITED is an FDA-registered facility (FEI 3003925108) located in JAIPUR R?jasth?n, IN. Registered operations: MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 28, 2025: Voluntary Action Indicated (VAI)
Inspections on record
5 (4 VAI, 1 NAI)
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

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 28, 2025Voluntary Action Indicated (VAI)No citations listed
Sep 13, 2019Voluntary Action Indicated (VAI)Absence of Written Procedures (21 CFR 211.100(a))
Feb 16, 2018Voluntary Action Indicated (VAI)Electronic records (21 CFR 11)
Training , Education , Experience overall (21 CFR 211.25(a))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Test methods (21 CFR 211.165(e))
and 7 more
Dec 5, 2017No Action Indicated (NAI)No citations listed
May 15, 2012Voluntary Action Indicated (VAI)Hand-washing facilities (21 CFR 111.15(i))
Physical plant - bulbs, fixtures, skylights (21 CFR 111.20(f))

FDA record score

9 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 VAIMar 28, 20256 x 16
Inspection classified VAISep 13, 20196 x 0.251.5
Inspection classified VAIFeb 16, 20186 x 0.251.5
Inspection classified VAIMay 15, 201210 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
Amol Pharmaceuticals Private Ltd.
Location
JAIPUR R?jasth?n (IN)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE
Source
both

FDA data resources

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