Drugs

Green Pharmaceuticals’ SnoreStop ‘Adulterated’: FDA

FDA says samples of the SnoreStop NasoSpray, a homeopathic product it obtained from Green Pharmaceuticals, Camarillo, CA, were adulterated because they consisted in whole or in part of a filthy, putrid, or decomposed substance. A 12/16/22 Warning Letter says the firm is registered with FDA as an over-the-counter human drug manufacturer. The letter says the agency has determined that the product also is adulterated because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to current good manufacturing practices (CGMP).

“FDA laboratory analysis determined that a sample of your SnoreStop was contaminated with Providencia rettgeri,” the letter says. “This contamination is particularly concerning because your SnoreStop product is a nasal spray and directed for use in children.”

Green recalled the lot of SnoreStop currently in distribution in the U.S. market. FDA says the company released finished drug products without adequate testing for critical microbial attributes. “You did not have scientific evidence regarding the potential presence of microbial contamination that is objectionable in view of its intended use,” the letter says. “Particularly for a drug product that is intended for use as a nasal spray, it is essential that your drug products are tested for microbial contamination to minimize the risk of patient exposure to significant numbers or harmful species of microorganisms, harmful microbial metabolites and/or toxins, and drug spoilage or degradation.”

FDA further determined that SnoreStop is an unapproved new drug even though it is labeled as homeopathic.

The letter reminds Green that it is responsible for the quality of its drugs regardless of any agreements in place with contract facilities.

FDA recommended that the company retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. Green was told to respond with a list of specific steps it has taken to correct any violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome