FDA WARNING_LETTER - Stokes Healthcare Inc. dba Epicur Pharma - October 25, 2023

The FDA issued a Warning Letter to Stokes Healthcare Inc. dba Epicur Pharma, an outsourcing facility, following an inspection from September 26 to October 25, 2023. The inspection revealed that drug products produced by the facility failed to meet Section 503B of the FDCA conditions and exhibited serious deficiencies in sterile drug production, posing patient risks.

Violations include misbranding due to inadequate labeling (missing inactive ingredient quantities and adverse event reporting information) and failure to submit adverse event reports per regulations. These issues render the compounded drugs ineligible for exemptions from FDA approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

The facility's drug products were deemed adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B) due to insanitary conditions and CGMP violations. Specific deficiencies included: - Failure to conduct integrity testing on filters used for sterilization. - Media fills not simulating challenging production conditions. - Inadequate smoke studies under dynamic conditions. - Insufficient contact time for sporicidal agents. - Deficient quality control unit responsibilities, investigations, and authority. - Lack of adequate written procedures for production, process control, and laboratory controls. - Failure to prevent microbiological contamination, validate aseptic processes, monitor environmental conditions, maintain adequate air supply, and ensure proper cleaning/disinfection.

The FDA found the company'