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Medical Devices / Inspections and Audits

Wound Dressing Manufacturer Falls Short On Quality Requirements

Dec. 13, 2018
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Devicemaker Winfield Laboratories was unable to produce quality control documentation for its N-Terface dressing, a Sept. 24 to Sept. 25 FDA inspection of the Richardson, Texas, facility revealed.

The material is a high-density polyethylene sheeting used as a primary dressing on newly applied skin grafts, laser skin resurfacing, partial-thickness burns, skin ulcers, chemical peels, dermabrasions and hair transplants. The company also manufactures sterile syringe seals and container seals.

Winfield Labs lacked design control procedures and design history files to demonstrate that its N-Terface material was developed according to design control requirements, the six-item Form 483 said.

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