FDA warning letter · Drugs

TRP Company, Inc

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your “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 2

Your “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 3

The CGMP violations identified at **(b)(4)** caused TRP’s drug products manufactured by **(b)(4)** to be adulterated.