Re-Gen Active Lab, Inc.
FDA issued a warning letter to Re-Gen Active Lab, Inc. (Irving, TX) regarding three amniotic membrane and umbilical cord tissue-derived cellular products — ActiveFlow™, ActiveShot™, and ActivePro™ — distributed to physicians and medical clinics nationwide. The products were found to be unapproved biological drugs lacking a valid Biologics License Application (BLA) or Investigational New Drug (IND) application, and failed to meet HCT/P homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a). FDA also documented nine significant CGMP deviations including failure to validate aseptic processes, inadequate sterility testing, and unsupported two-year expiration dating. The letter warns that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (3)
Using your products for orthopedic diseases or conditions, for example, is not homologous use as defined in 21 CFR 1271.3(c).
you assign a two-year expiration date to your products without supporting data
your products are intended to treat various diseases or conditions
Required actions (3)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
in order to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after showing that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an IND in effect as specified by FDA regulations.
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