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BioLab Sciences manufactured human cell and tissue products derived from amniotic fluid (Fluid GF, Restore GF, Fluid Flow, Amnio Restore, Stimuleyes) and epidermal skin tissue products (MyOwnSkin, MySkinRestore) that were marketed for therapeutic use but lacked proper FDA approval as biological products. The company's products met the definition of drugs and biologics under federal law yet were distributed without required licensure or compliance with 21 CFR Part 1271 regulations for human cells, tissues, and cellular products (HCT/Ps). The inspection, conducted in August-September 2021, documented that these products were marketed and distributed throughout the United States to healthcare professionals and third-party distributors, some under private label arrangements, despite not meeting regulatory requirements for either section 361 or section 351 compliance.