FDA EIR - Pall Newquay Ltd. - February 01, 2017

An FDA Level 2 QSIT inspection was conducted at Pall Newquay Ltd. in Cornwall, United Kingdom, from January 30 to February 1, 2017. This routine inspection, part of the DMPTI FY-17 medical device workplan, covered all four major quality subsystems, focusing on the company's intravenous line filter, a Class II medical device. While no FDA-483 was issued, indicating no significant regulatory violations, the inspection identified several areas for improvement.

Discussions with management highlighted the need to revise the firm's training procedure (PNQP-6016A) to specify timeframes for new employee reviews and ensure accurate transcription on training records. Additionally, environmental monitoring procedures (SOP 10545, SOP 9760) needed updating to explicitly state that sampling occurs during manufacturing activities, aligning documentation with current practice. Suggestions were also made to enhance the organization and presentation of Corrective and Preventive Action (CAPA) records for better clarity.

Pall Newquay Ltd. management acknowledged these points and committed to implementing the necessary revisions, including updating SOPs and initiating non-conformance reports to address the identified discrepancies. The firm's recall procedure was also reviewed, noting a proactive development of a new procedure for non-reportable field corrections, aligning with regulatory expectations under 21 CFR 806.