FDA EIR - Nexgen Pharma Inc - October 27, 2017

A U.S. Food and Drug Administration (FDA) inspection of Nexgen Pharma, Inc.'s Colorado Springs facility was conducted from October 23 to October 27, 2017. This comprehensive surveillance inspection, carried out under current Good Manufacturing Practice (cGMP) regulations and Compliance Program 7356.002, focused on drug manufacturing operations, including quality, production, facilities & equipment, and packaging & labeling systems. The inspection found that all six observations from a previous inspection in 2015 had been voluntarily corrected.

At the conclusion of the inspection, a one-item FDA Form 483, Inspectional Observations, was issued. The primary violation cited was that "Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair." Specifically, an exposed wall cavity with loose drywall dust was observed in a production room, posing a potential contamination risk. Nexgen Pharma's Vice President of Research and Development and Regulatory Submission, Dr. Deepak Thassu, acknowledged the observation and committed to implementing corrective actions. The company is required to submit a written response to the FDA within 15 business days outlining these actions. The FDA cautioned that failure to provide an adequate response could lead to further regulatory actions under the Food, Drug and Cosmetic Act, including warning letters, seizures, or injunctions.