483
Primera Analytical Solutions Corp.FDA 483 - Primera Analytical Solutions Corp. - April 12, 2024
Discuss this record with AI
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.
Record Details
Primera Analytical Solutions Corp., a control testing laboratory in Cranbury, NJ, was cited for significant deficiencies in its quality control unit. The firm failed to follow its own standard operating procedures for performing, documenting, and reviewing calculations and ensuring data integrity. Specifically, the quality unit did not verify calculations on unvalidated excel spreadsheets for method validation data and did not document data review for an ANDA.
Open in Dashboard
ID · 0402856d-01c4-4bec-b63b-65e8395eedab