Surgenex LLC — FDA Warning Letter Findings

Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)]. Specifically, your firm has not established an adequate system for environmental monitoring in the aseptic processing area where your products, SurCord® and SurForce®, are manufactured. You required environmental monitoring for the presence of microorganisms to be conducted on (b)(4) , which is insufficient to demonstrate control of the critical area during manufacturing.

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, your firm has assigned (b)(4) expiration date to your products without supporting data. We have reviewed your written responses, dated May 7, 2021, May 27, 2021, June 24, 2021, and July 30, 2021, to the…

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 SurCord® and SurFactor® with respect to identity, strength, quality, and purity. 1 4. Failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed. [21 CFR 211.192]. Specifically, your firm has failed to thoroughly investigate sterility failures. Between April 2017 and April 2021, you had eight sterility failures for which you identified the contaminating organism(s). You discarded the batches associated with sterility failures without conducting an investigation to determine the root cause of the failures. Examples of contaminating organisms identified include Propionibacterium species, Cutibacterium acnes, and Staphylococcus capitis .

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 (b)(4) of vials of SurCord® and SurForce® have not been validated (e.g., by performing media fill simulations) since your firm’s manufacturing operations began in…