483
Stira Pharmaceuticals LLCStira Pharmaceuticals LLC – FDA 483, Nov 5, 2021
Record Details
Atira Pharmaceuticals, LLC in Fairfield, NJ, a control testing laboratory, was inspected from October 27 to November 5, 2021. The inspection revealed significant deficiencies in computer system controls and software validation for laboratory equipment. These issues led to concerns regarding data integrity, as raw data files were accessible and deletable without proper audit trail capture or traceability.
View Company Profile
ID · 061bb232-4a42-46eb-a9ed-7fe00eec0422
Other documents for Stira Pharmaceuticals LLC
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.