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Pharmaceuticals / Regulatory Affairs

FDA Warns Eye Drop Manufacturers for CGMP Violations

May 22, 2019
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The FDA issued warning letters to four California firms for producing non-sterile homeopathic eyedrops.

The warnings targeted companies that worked together to manufacture and package Puriton Eye Relief Drops—Kadesh, U.S. Continental Marketing, Fill It Pack and Bershtel Enterprises. The agency’s analysis of product samples found a high pH level that could cause glaucoma, corneal scarring and loss of vision, as well as non-sterility that could lead to eye infection.

“When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk,” said FDA Acting Commissioner Ned Sharpless—flagging the agency’s intention to continue enforcement actions against homeopathy products.

Kadesh and U.S. Continental used contract manufacturers Fill It Pack and Bershtel, sending the contractors dropper bottles, tips and caps to use in manufacturing without making sure the companies could properly sterilize them. The contracting facilities lacked a filtered air supply, easily cleanable facility surfaces, environmental monitoring, and an aseptic system for the room and manufacturing equipment, the agency said.

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