FDA-Inspected Site

Coral Drugs Private Limited

4 FDA inspections are on record for Coral Drugs Private Limited in Rai, India.

483· Form 483 issued

Rai, India · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-08.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Apr 2025 – 8 Apr 2025Human Drugs483On file
19 Feb 2018 – 23 Feb 2018Human Drugs483View 483 →
7 Mar 2016 – 11 Mar 2016Human Drugs483On file
13 Nov 2010Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

23 Feb 2018
21 CFR 211.22(a)

Authority lacking to review records, investigate errors

Cited by Jai P Singh, Valerie L Whipp

23 Feb 2018
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Jai P Singh, Valerie L Whipp

23 Feb 2018
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Jai P Singh, Valerie L Whipp

23 Feb 2018
21 CFR 211.80(a)

Written Procedures Not Followed

Cited by Jai P Singh, Valerie L Whipp

Investigators

FDA investigators tied to this site in the record.

Mural B Gavini1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Coral Drugs Private Limited's 4 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat