Multiple Violations Found in Surgenex Inspection

A 4/5-4/16 FDA inspection at Surgenex, Scottsdale, AZ, determined that it manufactures cellular products for allogenic use that are distributed to third-party distributors, some under private label, and directly to healthcare professionals and medical facilities. An 11/15 Warning Letter says the products are intended for injection and are purported to be sterile. The letter says the products are considered to be drugs that are intended to treat diseases or conditions, including a variety of orthopedic diseases or conditions. They also are human cells, tissues, or cellular or tissue-based products that are regulated as biologic products requiring an approved BLA or IND, neither of which the company has. 

During the inspection, the letter says, FDA documented evidence of serious deviations from current good manufacturing practice (CGMP) requirements. The letter lists these CGMP deviations: 

•          failing 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;
•          failing to have an adequate system for monitoring environmental conditions in an aseptic processing area;
•          failing to establish written procedures for production and process control designed to ensure that drug products have the identity, strength, quality, and purity they purport or are represented to possess;
•          failing 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; and
•          failing to establish and follow a written testing program designed to assure the stability characteristics of drug products and to use the results of such stability testing to determine appropriate dosage conditions and expiration dates.

FDA reviewed the company’s responses to the inspection observations, the letter says, but because the agency identified additional significant deviations upon further review of the information collected during the inspection, the responses did not address some of the deficiencies.

The agency says it recognizes the company’s commitment to stopping the distribution of its three product lines and placing all remaining inventory in quarantine. FDA says a reinspection will be needed to verify the commitment and the adequacy of the firm’s responses to the inspection observations.

Surgenex was told to respond with a list of specific steps it has taken or plans to take to correct the noted violations and prevent their recurrence, with documentation showing that the correction has been achieved and a timetable for completing the work.