Devices

CPAPNEA Medical Supply Optipillows Violations

FDA says a 7/18-7/30/19 inspection at CPAPNEA Medical Supply, Phoenix, AZ, determined that the company manufactures the Optipillows EPAP mask that is adulterated because the company does not have an approved PMA in effect for the device. A 1/23 Warning Letter says the device is also misbranded the company did not notify FDA of its intent to introduce the device into commercial distribution.

While the firm has a cleared 510(k) for the mask for the sole indication of alleviating storing during sleep in adults, the device labeling and statements on the company Web site indicate that the device is intended to treat obstructive sleep apnea and may be a substitute for CPAP devices that is beyond the limitations of the cleared indications for use.

The letter gives examples of violative statements in the device labeling and on the Web site and also lists Quality System Regulation violations as:

failing to establish and maintain procedures for implementing corrective and preventive action;
failing to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities;
failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
failing to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine the effectiveness of the quality system;
failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record;
failing to establish a procedure for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to Medical Device Reporting requirements;
failing to establish a procedure for internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting;
failing to establish a procedure for internal systems that provide for timely transmission of complete medical device reports; and
failing to establish a procedure that describes how the firm will address documentation and record-keeping requirements.

The company was told to respond with a list of specific actions taken to correct the violations and prevent their recurrence, with documentation for each action and a timetable for completion.

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