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Coral Drugs Private Limited FDA Inspection Record

FEI 3003496619 · Inspections, Form 483s, warning letters and import refusals

Coral Drugs Private Limited is an FDA-registered facility (FEI 3003496619) located in Sonipat, IN. Registered operations: API MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 8, 2025: Voluntary Action Indicated (VAI)
Inspections on record
5 (5 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
2

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
Apr 8, 2025Voluntary Action Indicated (VAI)No citations listed
Dec 11, 2019Voluntary Action Indicated (VAI)No citations listed
Feb 23, 2018Voluntary Action Indicated (VAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Training , Education , Experience overall (21 CFR 211.25(a))
Buildings not maintained in good state of repair (21 CFR 211.58)
Written Procedures Not Followed (21 CFR 211.80(a))
Mar 11, 2016Voluntary Action Indicated (VAI)No citations listed
Nov 13, 2010Voluntary Action Indicated (VAI)No citations listed

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.

5 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIApr 8, 20256 x 16
Inspection classified VAIDec 11, 20196 x 0.251.5
Inspection classified VAIFeb 23, 20186 x 0.251.5
Inspection classified VAIMar 11, 201610 years or older, so it adds no points0
Inspection classified VAINov 13, 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 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
Coral Drugs Private Limited
Location
Sonipat (IN)
Registration Expires
Dec 31, 2027
Operations
API MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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