Devices

Linemaster Switch QS Violations

A 2/4-3/6 FDA inspection at the Linemaster Switch Corp. facility in Woodstock, CT, found Quality System Regulation violations in the firm’s manufacturing of foot pedal accessories for medical devices. A just-released 5/3 Warning Letter says the specific violations were:

failure to perform rework following documented procedures that account for the potential adverse effect of the rework on the product;
failure to document one or more processes for risk management in product realization;
failure to document corrective action procedures to determine the requirements for determining the causes of nonconformities and reviewing the effectiveness of corrective action;
failure to document the requirements for the work environment and the procedures to monitor and control the work environment, when conditions for the work environment can have an adverse effect on product quality; and
failure to document procedures for the validation of the application of computer software used for the monitoring and measurement of requirements.

The letter says FDA was unable to determine the adequacy of the firm’s responses to the inspection observations. It says a follow-up inspection will be required to ensure that corrections and/or corrective actions are adequate.

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

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