FDA 483 - Pfizer Ireland Pharmaceuticals Unlimited Company - May 11, 2023

An FDA inspection of Pfizer Ireland Pharmaceuticals in Grange Castle Business Park, Dublin, Ireland, from May 3-11, 2023, identified significant issues with the cleaning of classified areas. Observations included dirty equipment and floors in a Grade D classified room, as well as deficiencies in disinfectant efficacy studies that failed to challenge relevant surfaces. These findings indicate a need for improved environmental control and validation practices.