Failure to establish design controls, acceptance procedures or a quality policy for its MiBo Thermoflo Class II device landed specification developer and manufacturer Mibo Medical Group a Form 483 following a May inspection of its Dallas, Texas facility.
Marketed since 2014, the device hydrates eyes via an electric heating element that delivers continuous heat to the eyepad, which breaks down hardened lipids.
The firm had not defined, documented or implemented design control procedures that addressed design input, outputs, review, verification, validation or design changes, according to the nine-item 483.
Mibo had not established procedures for corrective and preventive actions and also failed to establish and maintain procedures for handling complaints, the agency said.
The facility did not maintain a device master record including device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications and maintenance and servicing procedures and methods.
“As a specification developer/manufacturer, your firm did not establish and maintain procedures to ensure that all purchased products and services conform to specified requirements in the manufacture of the MiBo Thermoflo,” the agency said.
The company was also cited for not establishing procedures for finished device acceptance to ensure the products meet acceptance criteria.
The firm also lacked procedures for quality audits and had not conducted any audits.