Champaklal Maganlal Homeo Pharmacy Private Limited
FDA issued a warning letter to Champaklal Maganlal Homeo Pharmacy Private Limited (India) for significant CGMP violations identified through a 704(a)(4) records request. The firm failed to conduct adequate identity testing on glycerin — a high-risk component used in OTC and homeopathic drug products — specifically to detect potentially lethal diethylene glycol (DEG) and ethylene glycol (EG) impurities. FDA placed all drugs manufactured by the firm on Import Alert 66-40 as of March 3, 2023, meaning products may be detained or refused admission at the U.S. border. The firm was directed to conduct risk assessments, test retain samples, and engage a CGMP consultant before resuming U.S. market manufacturing.
Required actions (5)
Within 30 calendar days upon receipt of this letter, provide the results of tests for DEG and EG in retain samples of all glycerin lots used in production of your glycerin-containing drug products.
A full risk assessment for drug products that contain glycerin and are within expiry in the U.S. market. Take prompt and appropriate actions to determine safety of all lots of this ingredient and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots.
you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market.
FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-40 on March 3, 2023, as the methods used in and controls used for the manufacture, processing, packing, or holding of these products do not appear to conform to current good manufacturing practices within the meaning of section 501(a)(2)(B) of the FD&C Act.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
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