CEO David Dalton of UNVC and CEO Patrick Kelly of 11THREE LLC may learn you do not put the Cart before the Horse, Under federal law and FDA regulations (21 U.S.C. § 352 & § 355), it is illegal to promote an unapproved drug product using commercial prescription labeling ("Rx Only"
or to solicit commercial distribution and sales partners without an approved New Drug Application (NDA/ANDA) or active NDC listing on file. https://11threetech.com/
Displaying mockups of finished prescription packaging complete with specific lot numbers (Lot-250501), expiration dates (EXP-2027-05), and an "Rx Only" legend crosses from exploratory disclosure into unlawful pre-approval promotion. Searches across official FDA registers—including the Orange Book, DailyMed, and the Electronic Drug Registration and Listing System (eDRLS)—confirm that no approved NDA/ANDA or active NDC exists for either UNVC or 11Three LLC.
While a Warning Letter is a common outcome for unapproved "Rx Only" promotion, the FDA sometimes issues an Untitled Letter or a Notice of Violation depending on the agency's formal intake assessment.
SEC and OTC Surveillance Coordination: Regulatory bodies frequently share information. An unaddressed or undisclosed FDA Warning Letter can lead market surveillance (such as OTC Markets) to issue a Caveat Emptor status or result in SEC administrative trading suspensions if public disclosures remain misleading or incomplete.
PL
or to solicit commercial distribution and sales partners without an approved New Drug Application (NDA/ANDA) or active NDC listing on file. https://11threetech.com/ Displaying mockups of finished prescription packaging complete with specific lot numbers (Lot-250501), expiration dates (EXP-2027-05), and an "Rx Only" legend crosses from exploratory disclosure into unlawful pre-approval promotion. Searches across official FDA registers—including the Orange Book, DailyMed, and the Electronic Drug Registration and Listing System (eDRLS)—confirm that no approved NDA/ANDA or active NDC exists for either UNVC or 11Three LLC.
While a Warning Letter is a common outcome for unapproved "Rx Only" promotion, the FDA sometimes issues an Untitled Letter or a Notice of Violation depending on the agency's formal intake assessment.
SEC and OTC Surveillance Coordination: Regulatory bodies frequently share information. An unaddressed or undisclosed FDA Warning Letter can lead market surveillance (such as OTC Markets) to issue a Caveat Emptor status or result in SEC administrative trading suspensions if public disclosures remain misleading or incomplete.
PL
