FDA 483 - Intergel Pharmaceuticals, LLC - November 20, 2018

An FDA inspection conducted at Intergel Pharmaceuticals, LLC between November 6 and November 20, 2018, identified two significant observations related to the company's manufacturing practices. The inspection revealed that the firm failed to consistently follow its established written procedures for the annual evaluation of drug products. Specifically, the Annual Drug Product Review for Nifedipine 10mg had not been performed since 2016, contrary to SOP QC-015-06. This indicates a gap in their quality system for ensuring ongoing product quality and compliance.

Additionally, the inspection highlighted deficiencies in the calibration program for mechanical equipment. Intergel Pharmaceuticals did not adhere to its written schedule for routine equipment calibration, as evidenced by the failure to calibrate a sanitary water meter on its due date of July 30, 2018. This uncalibrated equipment was subsequently used in the manufacture of a drug product, which resulted in a viscosity deviation for the finished product. Such a lapse raises concerns about the control and reliability of manufacturing processes.

As this document represents inspectional observations (Form FDA 483), Intergel Pharmaceuticals is required to address these findings. The company must provide a comprehensive response outlining its corrective and preventive actions to resolve these compliance issues and ensure adherence to good manufacturing practices.