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Amoli Organics (A Division Of Umedica Laboratories Pvt.Ltd) FDA Inspection Record

FEI 3004810446 · Inspections, Form 483s, warning letters and import refusals

Amoli Organics (A Division Of Umedica Laboratories Pvt.Ltd) is an FDA-registered facility (FEI 3004810446) located in Valsad, IN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 4, 2024: Voluntary Action Indicated (VAI)
Inspections on record
6 (5 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
Import refusals
3

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 4, 2024Voluntary Action Indicated (VAI)No citations listed
Jul 20, 2018No Action Indicated (NAI)No citations listed
Mar 31, 2017Voluntary Action Indicated (VAI)Design validation - software validation not performed (21 CFR 820.30(g))
Written sanitation procedures not followed (21 CFR 211.56(b))
Storage under appropriate conditions (21 CFR 211.142(b))
Feb 12, 2016Voluntary Action Indicated (VAI)No citations listed
Apr 24, 2014Voluntary Action Indicated (VAI)No citations listed
Sep 30, 2010Voluntary Action Indicated (VAI)No citations listed

FDA record score

5 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.

5 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 4, 20246 x 0.63.6
Inspection classified VAIMar 31, 20176 x 0.251.5
Inspection classified VAIFeb 12, 201610 years or older, so it adds no points0
Inspection classified VAIApr 24, 201410 years or older, so it adds no points0
Inspection classified VAISep 30, 201010 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
Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd)
Location
Valsad (IN)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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