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# CGMP Issues at India’s Champaklal Pharmacy
- URL: https://www.fdaweb.com/cgmp-issues-at-indias-champaklal-pharmacy/
- Published: 2023-04-11T12:00:00.000Z
- Updated: 2026-09-14T18:25:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154181

An FDA review of records submitted by Champaklal Maganlal Homeo Pharmacy Private Limited, a manufacturer of over-the-counter and homeopathic drug products in Ahmedabad, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/10 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/champaklal-maganlal-homeo-pharmacy-private-limited-652319-04102023?ref=fdaweb.com) says the specific violation was failing to conduct at least one test to verify the identity of each component of a drug product.

FDA recommends the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market.

The agency placed all drugs and drug products manufactured by the company on a 3/3 Import Alert. It says the drugs will remain on the alert until there is evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and FDA has confidence that future entries will comply with the law.

Champaklal was told to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.