FDA WARNING_LETTER - Champaklal Maganlal Homeo Pharmacy Private Limited - April 11, 2023

The FDA issued Warning Letter 320-23-13 to CMHP Private Limited, an Indian manufacturer of OTC and homeopathic drug products, on April 10, 2023. The letter followed a review of records submitted in response to a November 15, 2022, request under section 704(a)(4) of the FD&C Act.

The primary violation cited was the firm's failure to conduct identity testing for each component of a drug product, specifically glycerin (21 CFR 211.84(d)(1)). CMHP Private Limited did not adequately test each shipment of each lot of incoming high-risk glycerin for diethylene glycol (DEG) or ethylene glycol (EG) using the USP identification test. The firm's testing of retain samples of finished products using the 2018 Indian Pharmacopeia (IP) monograph for glycerin was deemed insufficient, as suitability for detecting DEG/EG in finished products was not demonstrated, and not every lot was tested.

Due to these CGMP violations, the firm's drug products are considered adulterated under section 501(a)(2)(B) of the FD&C Act. The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist in meeting CGMP requirements, including a comprehensive six-system audit.

All drugs manufactured by CMHP Private Limited were placed on Import Alert 66