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.
Read the Mibo Medical Form 483 here: www.fdanews.com/08-23-18-mibomedicalgroup483.pdf.
Executing an Audit
Planning and developing an internal audit program and training all involved personnel are tasks that take a lot of time and effort, but they are merely the foundation. Execution of the audit program comes with its own set of challenges, and is a more extensive activity than just checking items off a “to do” list in the audit procedures document.
Part of the established procedures should include steps taken to develop an audit plan for each individual audit. A one-size-fits-all plan will not work, as certain audits will, of necessity, have different goals and different purposes.
The beginning of any plan, according to Susan Reilly, owner of the consultancy Reilly & Associates, should be to ensure that all auditees necessary are available and aware that an internal audit is being scheduled. Someone on the audit team needs to be responsible for making sure that everyone who needs to be notified about an audit being scheduled is contacted. This includes anyone outside the company or business unit who may have responsibilities pertinent to the area being audited.
“I have been called in to do, say internal audits of a complaint process where I find out the corporate body has some responsibility for complaint-handling, yet no one there was notified that there was going to be an audit that day,” she said. “So, make sure all auditees are aware and the audit plan can help do that.”
In addition to ensuring that all auditees are available, audit team members need to be available, as well. Auditors should be identified, with responsibility for contacting them and clarifying the schedule clearly defined.
The audit plan should spell out the specific purpose or objectives of the audit being planned, as well as the scope or boundaries of what the audit will cover. It should specify what criteria — standards, regulations and internal procedures — will be applied during the audit. Other critical pieces of audit planning include:
Once the schedule has been set and confirmed, but well before the audit begins, the audit team should review past audit reports. This is especially important if part of the purpose of the current audit is to assess the effectiveness of previous corrections.
Excerpted from the FDAnews management report: Effective Internal Audits and Quality Control Units for Devicemakers.