FDA EIR - Cambrex High Point, Inc. - December 17, 2014

An FDA surveillance inspection of PharmaCore, Inc., an Active Pharmaceutical Ingredient (API) manufacturer located in High Point, NC, was conducted from December 15-17, 2014. The inspection was performed under Compliance Program 7356.002F, Active Pharmaceutical Ingredients, referencing ICH Q7A guidelines, as the firm operates under the U.S. Food, Drug and Cosmetic Act. PharmaCore produces non-sterile APIs primarily for Phase I and II clinical trials. While no formal Form FDA 483, Inspectional Observations, was issued, two significant items were discussed with management. Firstly, green release labels, essential for indicating Quality Assurance approval of materials, were found unattended in an unlocked drawer in the Sample Room. These labels were secured during the inspection. Secondly, the firm had not conducted testing on primary packaging materials, specifically LDPE bags, used for direct contact with APIs. In response, management committed to executing a newly developed protocol for testing product contact materials starting in January 2015. The FDA stressed that failure to address such conditions voluntarily could still lead to regulatory action.