FDA EIR - Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc. - April 12, 2019

An FDA inspection was conducted at UPM Pharmaceuticals, Inc. in Bristol, TN, from April 8 to April 12, 2019, under the regulatory framework of Current Good Manufacturing Practices (21 CFR 211). The inspection identified significant deficiencies in the company's manufacturing and quality control systems. Main violations included the failure to adequately manage environmental monitoring system alarms, leading to numerous unaddressed temperature, humidity, and pressure excursions. This resulted in the prolonged storage of capsules under conditions exceeding supplier recommendations, with these potentially compromised materials subsequently used in commercial and non-commercial products. The firm also exhibited inadequate documentation practices, evidenced by untracked production records, and failed to thoroughly investigate out-of-specification results, closing one investigation without determining a root cause or implementing corrective actions. Management acknowledged the findings on the FDA Form 483 and committed to retraining staff on alarm response, revising alarm acknowledgment responsibilities, conducting temperature mapping, and improving complaint and investigation documentation. They were informed of the requirement to formally respond to the FDA 483 observations within fifteen days.