FDA 483 - Primera Analytical Solutions Corp.

An FDA inspection of Pharm Analytical Solutions Corp. in Princeton, NJ, a Clinical & Bioanalytical CRO, identified four observations related to inadequate documentation and stability testing practices. The findings indicate deficiencies in the reconstruction of sample concentration rationales and the conduct of long-term stability experiments for residual drug amounts. These issues suggest potential concerns with data integrity and the reliability of analytical results.