FDA 483 - US Compounding Inc - August 21, 2015

US Compounding Inc. received an FDA Form 483 following an inspection from August 10 to August 21, 2015, revealing significant deficiencies in its operations as an outsourcing facility. The observations indicated potential violations of Current Good Manufacturing Practices (cGMP) for sterile drug product manufacturing. Key issues included inadequate cleaning and disinfection of aseptic processing areas, a failure to use sporicidal agents despite the presence of spore-forming organisms, and visible contamination during production. The facility's environmental monitoring system was found to be deficient, with repeated microbial contamination excursions in air and on personnel that were not thoroughly investigated or properly addressed. Furthermore, there were critical failures in the air supply systems, such as non-functional pressure alarms, uncalibrated gauges, and recorded negative pressure events in controlled environments. Procedures to prevent microbiological contamination were insufficient, lacking comprehensive media fills to simulate production conditions, validation of the lyophilization process, and proper operator qualification. The company also failed to perform 100% visual inspection of drug products, leading to distribution of contaminated vials, and demonstrated poor control over manufacturing processes, evidenced by numerous complaints regarding product integrity without proper efficacy assessment. Additional deficiencies included the absence of a written stability testing program, an unvalidated water purification system, inadequate preservative content testing, and deficient product labeling that omitted required statements and adverse event reporting information. Lastly, the company failed to submit required product production reports to the FDA. US Compounding Inc. is required to implement comprehensive corrective and preventive actions to resolve these systemic issues and achieve compliance.