Devices

Hologic QS and MDR Violations

A 7/30-9/24/2024 FDA inspection at Hologic in Marlborough, MA, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of Class 2 implantable radiographic markers such as its BioZorb product line. A just-released 12/18/2024 Warning Letter says specific violations were:

failure to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
failure to establish and maintain procedures for implementing corrective and preventive actions, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems using appropriate statistical methodology;
failure to submit a Medical Device Report to FDA no later than 30 days after the day the company received or otherwise became aware of information, from any source, that reasonably suggested that a device Hologic markets may have caused or contributed to a death or serious injury; and
failure to submit any report required within 10 days of initiating a correction or removal.

In the letter, FDA acknowledges that Hologic indicated it has decided to discontinue manufacturing the BioZorb product line.

Hologic was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule for their completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome