Primera Analytical Solutions Corp. – FDA EIR, Jun 2, 2015

An FDA surveillance inspection of Primera Analytical Solutions Corp., a pharmaceutical control testing laboratory in Princeton, NJ, was conducted from June 1-2, 2015. The inspection, which included both Good Manufacturing Practices (GMP) and Pre-Approval coverage for (b)(4) Oral Suspension, operated under the regulatory framework of FDA Drug Process and Drug Pre-Approval Inspections. Reviewing quality and laboratory control systems, standard operating procedures, sample handling, document changes, out-of-specification investigations, and employee qualifications, the FDA investigator found no deficiencies. The Pre-Approval portion, examining method development, test procedures, and data for submission batches, likewise revealed no issues and resulted in an approval recommendation for the (b)(4) Oral Suspension application. Consequently, no FDA-483 Inspectional Observations were issued. Although no regulatory violations were identified, management engaged in a discussion regarding the importance of precise sample identification, reporting all valid data, ensuring data accuracy and reliability, and maintaining comprehensive justification for any out-of-specification data invalidations.