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After US FDA Finds ‘Particularly Concerning’ GMP Problems, Homeopathic Firm Continues OTC Sales

 
• By Malcolm Spicer

A warning letter submitted by FDA Office of Regulatory Affairs’ Division of Pharmaceutical Quality Operations I in New Jersey notes that Homeocare Laboratories indicated to agency officials that it no longer is manufacturing OTC drugs.

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New York firm Homeocare Laboratories Inc. is “particularly concerning” to the US Food and Drug Administration because its manufactured OTC products containing toxic ingredients, some indicated for children, with poor documentation, testing and cleaning procedures.

A warning letter submitted on 22 June by the Office of Regulatory Affairs’ Division of Pharmaceutical Quality Operations I in...

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More from Policy & Regulation

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