FDA 483 - Downing Labs, LLC - April 16, 2013

An FDA inspection of NuVision Pharmacy, Inc., a Dallas-based producer of sterile drug products, conducted from March 18 to April 16, 2013, uncovered critical deviations from Good Manufacturing Practices. The most prominent issues involved a systemic failure to prevent microbiological contamination. Deficiencies included inadequate validation of aseptic processes, such as media fills that did not simulate worst-case conditions, and unvalidated sterilization methods for both drug products and equipment. Lyophilization cycles were also unvalidated, and environmental controls like dynamic smoke studies and daily air monitoring were lacking or insufficient. The inspection further revealed a critical failure to thoroughly investigate product quality issues. This included inadequate investigations into patient complaints linked to injectable products, numerous unaddressed potency failures (approximately 110 instances), and the consistent release of product batches without proper re-testing or root cause analysis. Contaminants like fibers and particulates were found in many injectable lots without investigation, and their inspection method was unvalidated. Additional observations highlighted the absence of a scientific stability program to support Beyond Use Dates and a lack of antimicrobial effectiveness testing. Aseptic area cleaning and disinfection procedures were inadequate, utilizing unvalidated disinfectants and exhibiting inconsistent cleaning schedules. Personnel gowning practices for aseptic operations were also found deficient, failing to require sterile masks, gloves, or full body coverage. NuVision Pharmacy, Inc. is required to implement comprehensive corrective and preventive actions to rectify these substantial quality and control issues in its sterile drug manufacturing operations.