Mr. Dhaval Kapadia
Director
Champaklal Maganlal Homeo Pharmacy Private Limited
701, SAFAL PRELUDE 100 Ft. Ring Road
Nr. Ashwaraj Bunglow, Corporate Road
Prahlad Nagar, Ahmedabad 380015
Gujarat
IndiaFEI 3018725547Issued Apr 10, 2023Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3018725547.
Mr. Dhaval Kapadia
Director
Champaklal Maganlal Homeo Pharmacy Private Limited
701, SAFAL PRELUDE 100 Ft. Ring Road
Nr. Ashwaraj Bunglow, Corporate Road
Prahlad Nagar, Ahmedabad 380015
Gujarat
India
FEI Number
3018725547
Country
India
Issue Date
April 10, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Champaklal Maganlal Homeo Pharmacy Private Limited, an India-based manufacturer of over-the-counter and homeopathic drugs, failed to comply with current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company did not conduct adequate identity testing on incoming components, specifically high-risk glycerin used in formulations at elevated percentages, in violation of 21 CFR 211.84(d)(1). These violations were identified during FDA's review of records submitted in response to a November 2022 section 704(a)(4) records request.
Champaklal Maganlal Homeo Pharmacy Private Limited FDA Warning Letter, April 10, 2023
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