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The other 167 letters, the non-inspection-based warning letters, were issued pursuant to either a website, labeling, and/or promotional communications review (143 letters), a records request for remote evaluation of a facility under section 704(a)(4) of the FDCA (704(a)(4) request) (22 letters), 2 or a failure to register and list a product (electronic drug registration and listing system violations, eDRLS) (two letters)

Medina-Lezama J, Zea-Diaz H, Morey-Vargas OL, Bolaos-Salazar JF, Muoz-Atahualpa E, Postigo-MacDowall M, Corrales-Medina F, Valdivia-Ascua Z, Cuba-Bustinza C, Paredes-Daz S, Villalobos-Tapia P, Chirinos-Pacheco J, Goldberg RB, Chirinos JA