Western Enterprises was cited in a Form 483 for inadequate investigations of and responses to complaints at its Westlake, Ohio, facility.
The FDA cited the manufacturer of oxygen tanks, gauges and fittings for five observations.
The inspector’s first observation found that Western failed to document an investigation of complaints involving the possible failure of a suction regulator to meet its specifications. For example, a complaint reported that the device malfunctioned, but Western did not have the device analyzed.
The 483 also cites Western for failing to completely document all corrective and preventive actions taken in response to a complaint that a production unit had leaked.
The inspector also found that Western failed to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and procedures to ensure that all purchased or otherwise received products and services conformed to specified requirements.
Finally, the inspector said that Western had not validated certain processes and product lines according to established procedures.