483
Pfizer Ireland Pharmaceuticals Unlimited CompanyPfizer Ireland Pharmaceuticals Unlimited Company – FDA 483, May 11, 2023
Record Details
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.
View Company Profile
ID · aa02473c-1999-4603-ab70-50607957c9d0
Other documents for Pfizer Ireland Pharmaceuticals Unlimited Company
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.