FDA-Inspected Site

Kothari Phytochemicals International

4 FDA inspections are on record for Kothari Phytochemicals International in Madurai, India.

483· Form 483 issued

Madurai, India · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-29.

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
26 Aug 2025 – 29 Aug 2025Human Drugs483View 483 →
4 Nov 2019 – 8 Nov 2019Human Drugs483On file
5 Dec 2016 – 9 Dec 2016Human Drugs483On file
22 Dec 2010Not recorded483On file

Observations on record

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

29 Aug 2025
21 CFR 211.68(b)

Computer control of master formula records

Cited by Jared P Stevens

Investigators

FDA investigators tied to this site in the record.

Ariel Cruz Figueroa1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Kothari Phytochemicals International's 4 Form 483s

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