FDA 483 - Primera Analytical Solutions Corp. - April 12, 2024

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.