FDA EIR - União QuÍmica Farmacêutica Nacional SA - February 23, 2016

Laboratorios Pfizer Ltda., a manufacturer of sterile prescription animal drug products in Guarulhos, State of Sao Paulo, Brazil, underwent an FDA inspection from February 15 to February 23, 2016. The inspection, conducted under the Current Good Manufacturing Practices (CGMP) framework as per 21 CFR 210/211 and compliance program 7371.001 for Animal Drug Manufacturing Inspections, aimed to evaluate the firm's adherence to these standards. The scope covered Quality, Facilities and Equipment, Materials, Packaging and Labeling, and Laboratory Control systems.

Notably, the inspection concluded with no objectionable conditions formally cited, and no FDA Form 483 was issued. The firm's cGMP status was deemed acceptable, resulting in a "No Action Indicated" (NAI) classification. However, a verbal observation was made regarding delays in completing and reporting stability analysis for a specific product lot. While no formal actions were mandated, addressing this observation would ensure continued compliance. The previous inspection in 2012 had resulted in one objectionable condition related to Facilities and Equipment, which was subsequently classified as Voluntary Action Indicated (VAI). This current inspection demonstrates significant improvement.