Devices

Multiple Agena Bioscience Violations

FDA says its 6/7-6/13/2023 inspection at Agena Bioscience in San Diego, CA, determined that the firm manufactures the MassARRAY4 system and iPLEX HS chemistry panels in vitro diagnostic products, including the iPLEX HS colon panel. A 3/21 Warning Letter says the colon panel is adulterated because the firm does not have an approved PMA or IDE for the product. It also is misbranded because Agena did not notify FDA of its intent to introduce the product into commercial distribution, the letter says.

FDA says company officials told the agency investigators that it no longer markets the products for which it had obtained clearance in the past. The agency also says that although the company claims the colon panel is marketed only for research use, there are indications on the firm’s Web site and in statements from officials indicating that it is intended for clinical diagnostic use.

FDA says the colon panel also is misbranded because Agena failed to tell FDA about a correction or removal of a device initiated to reduce a risk to health posed by the device.

“We request that your firm immediately cease any activities that result in misbranding or adulteration of your devices,” the letter says. “Your firm should take prompt action to correct any violations.”

Agena was told to respond with a list of specific actions it has taken to address the concerns noted in the letter, with documentation of the actions and a timetable for completing the work.

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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