FDA EIR - FOCUS Laboratories, Inc. - April 26, 2018

Focus Laboratories, Inc. underwent an FDA follow-up inspection from April 23 to April 26, 2018, in North Little Rock, AR. This inspection, conducted under CPGM 7356.002 for Drug Manufacturing Inspections, focused on the human drug product FreshKote Lubricant Eye Drops, as a follow-up to a previous inspection in 2015 which resulted in a ten-item Form FDA 483. The current inspection aimed to verify the resolution of past deficiencies related to quality, equipment/facilities, and aspects of materials and packaging/labeling systems.

The previous inspection identified significant issues, including inadequate stability studies, incomplete batch records, insufficient annual product reviews, deficient acceptance criteria for testing, poor complaint investigation, lack of routine equipment calibration, improper reserve sample maintenance, inadequate personnel training, and unwritten/unfollowed quality control unit procedures.

During the 2018 follow-up, Focus Laboratories demonstrated substantial improvements. The company implemented a new Quality Management System in August 2017, revised standard operating procedures for complaints and calibration, and provided documentation addressing all applicable previous observations. Notably, they changed contract manufacturers and bottle designs for FreshKote due to past complaints. The FDA investigator found no deficiencies during this inspection, confirming that the company had effectively addressed the issues from the prior audit. Consequently, no Form FDA 483 was issued, and the inspection concluded without observations.