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FDA Warning Letter Explorer
FDA warning letter · Drugs

Salvacion USA 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

Based on our review, Covixyl Nasal Spray is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.128