BioLab Sciences, Inc. – FDA Warning Letter, Sep 3, 2021

On August 23, 2022, the FDA issued a Warning Letter to BioLab Sciences, Inc. following an inspection from August 23 to September 3, 2021. The inspection revealed that BioLab Sciences manufactures and distributes human amniotic fluid products (Fluid GF™, Restore GF™, Fluid Flow™, Amnio Restore™, (b)(4), and Stimuleyes™) and epidermal skin tissue products (MyOwnSkin™ and MySkinRestore™). The FDA determined these products are unapproved drugs and biological products, requiring a Biologics License Application (BLA) or an Investigational New Drug (IND) application, neither of which are in effect. MyOwnSkin™ and MySkinRestore™ were also found to be more than minimally manipulated and not for homologous use, failing to meet HCT/P criteria under 21 CFR 1271.10(a).

The letter cited significant Current Good Manufacturing Practice (CGMP) deviations, including: 1. Failure to validate aseptic and sterilization processes for sterile products (21 CFR 211.113(b)). 2. Inadequate laboratory controls and product specifications (21 CFR 211.160(b)). 3. Failure to establish and follow written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)). 4. Failure to establish and follow written sanitation procedures