FDA EIR - Padagis US LLC - July 07, 2017

An FDA inspection of Paddock Laboratories, LLC. in New Hope, MN, was conducted from June 7 to July 7, 2017. This comprehensive surveillance and pre-approval inspection, guided by current Good Manufacturing Practice (cGMP) regulations (21 CFR 210 & 211) and International Conference on Harmonisation (ICH) guidelines, aimed to evaluate the facility's readiness for commercial manufacturing, adherence to application standards, and data integrity.

The inspection identified nine significant deficiencies, resulting in an FDA Form 483. Main issues spanned four key areas: Quality, Facilities and Equipment, Production, and Laboratory Control. Violations included the quality control unit's failure to fully follow written procedures for investigations and risk assessment, and the absence of a formal Quality Risk Management procedure. Laboratory controls lacked scientifically sound test procedures, with critical calculations often omitted from records. Equipment calibration and qualification were found inadequate, missing routine checks and proper requalification protocols. Furthermore, master production and control records were incomplete, and process validation for manufacturing variability was insufficient.

Company management, including the Vice President and Senior Director of Quality Operations, acknowledged the observations and committed to submitting a written response within 15 business days. The FDA warned that these observations could be deemed violations of the Food, Drug and Cosmetic Act, potentially leading to sanctions if not voluntarily corrected.