Pda Laboratories, Inc. – FDA EIR, Nov 15, 2022

PDA Laboratories, Inc. underwent a Pre-Approval Inspection (PAI) by the FDA from November 14-15, 2022, focusing on its contract microbiological testing operations for a specific pharmaceutical product. This inspection was conducted under Compliance Program 7346.832. While no formal Form FDA 483, Inspectional Observations, was issued, four significant issues were verbally discussed with company management during the close-out meeting.The main concerns included insufficient temperature monitoring for incubators and refrigerators used for media storage and sample incubation, lacking continuous data recording and alarm systems. Furthermore, the firm had not performed temperature mapping of these critical units under actual, loaded conditions. The Quality Unit's oversight was also deficient, as growth promotion test results for microbiological media were not reviewed and signed by them. Finally, the company's Standard Operating Procedure for Out-of-Specification (OOS) investigations was deemed inadequate, as it failed to include comprehensive instructions for reviewing all potential impacting factors such as growth promotion results, positive/negative controls, or incubator settings.President Artur Lewandowski acknowledged these observations and committed to implementing corrective actions. These actions include enhancing continuous temperature monitoring, re-qualifying incubators and refrigerators under loaded conditions, and updating relevant SOPs to ensure Quality Unit review of growth promotion tests and a more thorough OOS investigation process.