FDA WARNING_LETTER - Fagron Compounding Services - September 21, 2016

The FDA issued a Warning Letter to Fagron Compounding Services, LLC dba Fagron Sterile Services following an inspection from August 29 to September 21, 2016. The facility, registered as an outsourcing facility, was found to have serious deficiencies in producing sterile drug products, rendering them adulterated under section 501(a)(2)(B) of the FDCA due to CGMP violations.

Key violations include: 1. Failure to establish and follow adequate written responsibilities and procedures for the quality control unit (21 CFR 211.22(d)). 2. Failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192). 3. Failure to conduct appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.165(a)).

The FDA found the company's October 7, 2016, response to the Form FDA 483 inadequate. Specifically, the response regarding the review of building management system (BMS) alarms was insufficient, lacking a clear rationale for critical vs. non-critical alarms and an updated BMS procedure. Other corrective actions, such as revised SOPs for visual inspection and product release (including post-use filter integrity testing), could not be fully evaluated due to a lack of supporting documentation.

The FDA emphasized that the company