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Regulatory Focus™ > News Articles > 12 > Updated: FDA Flags Lack of Design Controls at Mibo Medical Group

Updated: FDA Flags Lack of Design Controls at Mibo Medical Group

Posted 25 February 2020 | By Ana Mulero 

Updated: FDA Flags Lack of Design Controls at Mibo Medical Group

The US Food and Drug Administration (FDA) last November sent a letter to Texas-based Mibo Medical Group to say that the firm addressed the violations in a warning letter from December 2018.

"Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections," FDA said.

An inspection at the site previously revealed a lack of established procedures for controlling the design of its class II dry eye treatment device, distributed since 2014.

The firm drew an FDA warning letter over nine significant violations of good manufacturing practices (GMP). The warning letter is largely focused on FDA’s observed failures around the firm’s lack of procedures to control the design of its class II MiBo Thermoflo medical device.

Mibo Medical Group had yet to establish procedures for design inputs, design outputs or design verification and validation for its eye treatment device at the time of the agency’s three-day inspection in May, according to the warning letter. The firm, for example, had failed to validate the temperature testing method applied to the MiBo Thermoflo eyepiece prior to releasing the device to US customers.

When the FDA investigator sought to inspect procedures for design inputs, the firm provided two documents. The “First mock up prototypes” document included “rough sketches of the device and handwritten notes” while the “Reports + Studies” document was “a chain of emails from 2014” the firm had “emailed to an unidentified recipient” with study abstracts, the agency said. Neither “included procedures to ensure the design requirements are appropriate and address intended use of the device.”

The firm was also found to have been lacking enough evidence to demonstrate compliance with FDA procedural requirements for the initial design, design transfer or subsequent device design changes on its MiBo Thermoflo device. Failures to establish and maintain a design history file for each device type and to conduct risk analysis to identify possible design hazards were both cited in the warning as well.

The remaining eight GMP violations are similar in that they also cite failures to establish other legally required procedures. FDA noted Mibo Medical Group did not have any procedures for corrective and preventive actions (CAPA) as it had been “unaware of the requirements” for CAPA procedures.

The firm also lacked procedures for evaluating its suppliers, contractors and consultants or for finished device acceptance, complaint handling, adverse event reporting, maintaining a device master record for the MiBo Thermoflo device and conducting internal audits as required by FDA, according to the warning letter. “No quality policy was available for review during the inspection” either and “no evidence was provided” to demonstrate the firm’s quality system underwent management’s review as required.

FDA noted the firm had lacked complaint handling procedures and had failed to document any complaints received from customers since it began manufacturing and distributing its MiBo Thermoflo device in 2014. This is despite citing a 95% customer satisfaction rate on the product’s website.

The warning letter escalated 483 observations at a Plano plant after an FDA review of responses from May and October concluded the firm had yet to provide “objective evidence of corrections made.” 

Mibo Medical Group 11/20/18

Editor's note: Article updated on 2/25/20 to note the closeout letter from FDA.

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