FDA 483 - BioStem Life Sciences - September 15, 2023

From September 11-15, 2023, the FDA inspected BioStem Life Sciences, a manufacturer located at 2836 Center Port Cir, Pompano Beach, FL. The inspection, led by Investigators Annette Melendez, Ivan E Reyes, and Sergio E Delgado, resulted in a Form 483 being issued to CEO Jason V. Matuszewski.

Observation 2 noted that the firm failed to conduct appropriate laboratory determination of satisfactory conformance to final specifications, identity, and strength of each active ingredient prior to releasing drug products. Specifically, from January 1, 2021, to September 13, 2023, BioStem Life Sciences released (b)(4) units of amniotic fluid and amniotic membrane derived products (RHEO) and umbilical cord derived products (OROPRO, Product (b)(4), Product (b)(4), and Product (b)(4)) without performing these critical tests. These products were distributed via interstate commerce, including various quantities of AF RHEO, OROPRO, and other specified products.

Observation 3 indicated that drug products lacked expiration dates determined by appropriate stability data to ensure they meet applicable standards of identity, strength, quality, and purity at the time of use. This applied to amniotic fluid and amniotic membrane derived products (RHEO) and umbilical cord derived products (OROPRO, Product (b)(4), Product (