Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your “Dryness Relief,” “Pink Eye Relief,” “Allergy Eyes Relief,” “Red Eye Relief,” “Eye Strain Relief,” “Eye Lid Relief,” “Aging Eye Relief,” “Blur Relief,” “Floaters Relief,” “Twitching Relief,” “Stye Relief,” and “Dryness Relief PF” products are
Passage 2Your “Dryness Relief,” “Pink Eye Relief,” “Allergy Eyes Relief,” “Red Eye Relief,” “Eye Strain Relief,” “Eye Lid Relief,” “Aging Eye Relief,” “Blur Relief,” “Floaters Relief,” “Twitching Relief,” “Stye Relief,” and “Dryness Relief PF” products are not generally recognized as safe and effective (GRASE) for their above referenced uses
Passage 3The CGMP violations identified at **(b)(4)** caused TRP’s drug products manufactured by **(b)(4)** to be adulterated.