Devices

QS Violations at LeMaitre Vascular

A 3/4-4/16 FDA inspection at the LeMaitre Vascular facility in North Brunswick, NJ, found Quality System Regulation violations in the firm’s manufacturing of Artegraft Collagen Vascular Grafts. An 8/11 Warning Letter says the specific Quality System violations were:

failure to establish and maintain procedures to prevent contamination of equipment or products by substances that could reasonably be expected to have an adverse effect on product quality;
failure to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality;
failure to validate with a high degree of assurance according to established procedures a process whose results cannot be fully verified by subsequent inspection and test;
failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met;
failure to verify or validate corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device; and
failure to establish and maintain procedures for implementing corrective and preventive action.

The letter says the firm’s responses to the Quality System regulation inspection observations were either inadequate or their adequacy could not be determined.

FDA also says LeMaitre failed to submit any report required within 10 working days of initiating a correction or removal.

The company was told to promptly address the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.

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