FDA EIR - Pfizer, Inc. - August 14, 2013

An FDA limited inspection of Pfizer, Inc. at its Collegeville, PA facility was conducted on August 14, 2013. The one-day inspection focused on the company's role as a pharmaceutical commercial sponsor. Although the assignment number was under the Philadelphia District's Food Safety Modernization Act (FSMA) work plan, no food products were distributed or covered at this location. Notably, this inspection concluded without any FDA-483 Inspectional Observations, indicating that no significant issues or deviations were identified by the investigator. This outcome contrasts with a previous inspection on June 6, 2013, which resulted in a Voluntary Action Indicated (VAI) classification. For the current inspection, there were no refusals, no samples collected, and no pest activity observed. Consequently, the FDA did not require any specific corrective actions or impose any regulatory measures on Pfizer, Inc. following this assessment.