FDA EIR - Georgia Pacific Corporation - February 08, 2019

An FDA inspection was conducted at Georgia Pacific Corporation, located in Atlanta, GA, on February 8, 2019. This initial inspection, performed under the Foreign Supplier Verification Program (FSVP) framework, focused on the company's import activities, specifically concerning packaged pepper. The inspection resulted in a "No Action Indicated" (NAI) classification, with no formal observations issued. However, the FDA provided recommendations for improvements to Georgia Pacific's existing FSVP. Key areas for enhancement included ensuring that hazard analyses were formally documented as reviewed and assessed by a qualified individual. Additionally, the FDA suggested broadening the scope of the FSVP, which appeared to focus primarily on the foreign supplier's practices, to fully address the importer's responsibilities. It was also noted that the firm did not fully comply with all records maintenance requirements under 21 CFR 1.510, particularly regarding signing and dating FSVP records upon completion or modification. Management at Georgia Pacific Corporation was provided with educational materials on FSVP regulations and committed to implementing immediate corrective actions. The FDA confirmed that during this "Educate while we Regulate" phase, no compliance actions would be taken, emphasizing education and voluntary correction.