Kothari Phytochemicals International, Madurai, India – FDA Inspections

Inspection records and compliance data for Kothari Phytochemicals International in Madurai. 4 FDA inspections on record, 2 Form 483s, last inspected August 29, 2025.

Company Profile

This profile covers Kothari Phytochemicals International based in Madurai, India.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 4
NAI: 0
Form 483s: 2
Warning letters: 0

First inspected December 22, 2010. Last inspected August 29, 2025.

Most cited issue areas

Computer control of master formula records1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
August 29, 2025	VAI	Human Drugs · Drug Quality Assurance	1280138
November 8, 2019	VAI	Human Drugs · Drug Quality Assurance	1111221
December 9, 2016	VAI	Human Drugs · Drug Quality Assurance	996110
December 22, 2010	VAI	Human Drugs · Drug Quality Assurance	703177

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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