Peregrine Surgical Ltd – FDA Warning Letter, Jul 15, 2010

An FDA inspection of Peregrine Surgical, Ltd. from June 29 to July 15, 2010, revealed that their Adjustable Laser Probes and Light Pipes are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to establish and maintain a design history file (21 CFR 820.30(j)), specifically DCN 1524 for the Adjustable Laser Probe, lacking documentation of design control procedures (QAP27-02, -03, -05, -06). The firm's response of ceasing distribution and recalling the product was deemed inadequate as it didn't address preventing recurrence for all applicable devices. 2. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)(2)), evidenced by inadequate investigation into particulates in finished devices and an unjustified reject rate. The firm's response to revise procedures to reflect current practices was inadequate, as current practices should align with approved procedures. 3. Failure to establish and maintain adequate finished device acceptance procedures (21 CFR 820.80(d)), as visual inspection criteria