INCELL Corporation LLC — FDA Warning Letter Findings

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 CFR211.113(b)]. For example, the aseptic processes used to manufacture your product have not been validated (e.g., by performing media fill simulations) since your firm’s manufacturing operations for the subject product began in February…

Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity [21 CFR211.160(b)]. For example, you have not established scientifically sound and appropriate specifications to assure that your product conforms to…

Failure to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)]. Specifically, your certificate of analysis for your product states that the expiry period is (b)(4) , while your instructions for use (IFU) labels your product as having a “ (b)(4) .” You therefore assigned (b)(4) expiration dates to…