Green Pharmaceuticals Inc.
FDA issued a warning letter to Green Pharmaceuticals Inc. (Camarillo, CA) regarding its OTC homeopathic nasal spray product SnoreStop NasoSpray, which was found to be adulterated with gross microbial contamination (Providencia rettgeri, with counts up to 6,200 CFU/mL) and manufactured without adequate CGMP controls. The product was also found to be an unapproved new drug under section 505 of the FD&C Act, as its labeling made drug-use claims without an FDA-approved application. A voluntary recall of the contaminated lot was conducted in June 2022, and FDA warned that failure to correct violations could result in seizure, injunction, and withholding of approvals.
Flagged claims (4)
SnoreStop
Temporarily helps stop or reduce symptoms of non-apneic snoring
Helps stop or reduce the symptoms of snoring
ANTI-SNORING
Required actions (4)
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.
Failure to promptly and adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
Failure to promptly and adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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.
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