Pfizer Manufacturing Belgium NVJune 8, 2023

FDA 483 - Pfizer Manufacturing Belgium NV - June 08, 2023

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Record Details

An FDA inspection of Pfizer Manufacturing Belgium NV in Puurs-Sint-Amands, Belgium, identified one observation related to inadequate documentation of corrective and preventive action (CAPA) activities. Specifically, investigations into injector pen device complaints, such as blockages and underfills, lacked sufficient documentation. This indicates a deficiency in the firm's quality system regarding CAPA record-keeping.

Company: Pfizer Manufacturing Belgium NV
Inspection Date: June 8, 2023
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Catherine J. Laufmann (Consumer Safety Officer)

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ID · a3ec07be-9ab6-4d43-be1a-7f2a3034c654