Davati Medical Supply LLC

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, this product is an unapproved new drug under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355.

Passage 2

Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352.

Passage 3

Your product is also an unlicensed biological product under section 351 of the Public Health Service Act (PHS Act), 42 U.S.C. § 262.

Passage 4

Your product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect for your product.

Passage 5

“FLUZALP™ Quadrivalent is an inactivated Influenza vaccine indicated for active immunization against Influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUZALP QUADRIVALENT is approved for use in persons 4 years of age and older.”

Passage 6

“The quadruple strain formula provides protection for up to 6 months*. The product’s dosage form is injection, suspension and is administered via intramuscular form.”

Passage 7

“Each batch of these vaccines is then tested by FDA for Quantity, Quality and Efficacy before being release [sic] into the market.”