CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers

Regulatory NewsRegulatory News | 06 September 2017 |  By 

About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.

The warning letters were sent from February through August 2017 to three manufacturers from the US, and five  in Brazil, the Netherlands, Germany, China and Bulgaria.

The release of the letters follows a story in Bloomberg News highlighting that CDRH had only previously released one warning letter in 2017, which was a fraction of the number issued in previous years.

US Warning Letters

In the US, CDRH warned Boston-based SyncThink in July for marketing an eye impairment device without clearance or approval.

Henderson, Nevada-based Steiner Biotechnology also received a warning letter for not complying with federal regulations while conducting clinical studies for two products, known as Ridge Graft and Skeletal Graft.

And Plymouth, Minnesota-based Entellus Medical received a warning letter in April for deviating from clinical trial protocols in a study of a multi-sinus dilation system.

“At multiple clinical sites, Entellus Medical clinical personnel were present during procedures that included protocol deviations consisting of use of the device on the frontal and sphenoid sinuses of pediatric subjects under the age of 12,” the letter says.

Foreign Warning Letters

CDRH also sent a warning letter to Brazil-based MB Industria Cirurgica Ltda on 4 August, with 10 observations related to the company’s failures in manufacturing wound dressings.
Netherlands-based QLRAD received a warning letter in July for marketing the RectalPro Endorectal Balloon (ERB) in the US without marketing clearance or approval.

China-based Hebei Pukang Medical Instruments Co., Ltd. received a warning letter in March for its failures in manufacturing AC-powered adjustable beds, wheeled stretchers, manual beds, cabinet trays and operating room table and attachments.

Sofia, Bulgaria-based X12, meanwhile, received a warning letter sent in March for manufacturing adulterated sterile reflective marker spheres.

And Berlin-based G L E Gesellschaft für lichttechnische Erzeugnisse GmbH received a warning letter in February

SyncThink, Inc. 7/31/17

Steiner Laboratories 6/21/17

Entellus Medical 4/6/17

MB Industria Cirurgica Ltda 8/4/17

HOSPIMED 7/20/17

Hebei Pukang Medical Instruments Co., Ltd. 3/29/17

X12 Co., LTD. 3/23/17

G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh 2/23/17


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