Row1 Inc. dba Regenative Labs — FDA Warning Letter Findings

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)]. Specifically, you have not validated the manufacturing processes for your products with respect to identity, strength, quality, and purity. For example, your validation for umbilical cord processing only included bioburden testing as a measurement of product attributes.

Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR 211.113(b)]. For example: a. The aseptic processes used to manufacture your products have not been validated (e.g., by performing (b)(4) ) since your firm’s manufacturing operations began in February 2020. Your products purport to be…

Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)]. Specifically, you assign a five-year expiration date to your products without supporting data regarding the stability characteristics of the products. 1 We have received and reviewed your written responses, dated April…