A company that makes electrode caps used to monitor brain activity during surgery has received a warning letter from the U.S. Food and Drug Administration.
The warning letter to Eaton, Ohio-based Electro-Cap International cited violations primarily involving the documentation of manufacturing and design processes.
Warning letters are considered by the FDA to be informal and advisory, and don’t necessarily indicate that the FDA intends to take any punitive action against recipients.
The Dayton-area company was cited for failing to establish procedures around the documentation and testing of design changes before the changes were implemented.
For example, the FDA said the company didn’t document its research into the impact of design changes to the viscosity of its Electro-Gel product, which is used for conduction between an electrode and the skin.
Electro-Cap was also cited for failing to document testing of design changes to the electrodes and connectors of its flagship Electro-Cap product, which is used for intraoperative electroencephalography (EEG) monitoring.
William Hardin, the company’s president, said Electro-Cap is filing new 510(k) applications for both of the products and the new applications should address the FDA’s concerns.
The original 510(k) for one of the products was filed in 1978, he said. Given that date, it’s not a surprise that the company made changes to the product in subsequent years.
Most of the issues cited by the FDA stemmed from errors the company made in its documentation, rather than a failure to follow the proper manufacturing processes, Hardin said. In one case, “We did what we needed to do, it just wasn’t on the right document,” he said.
The violations were uncovered during an April FDA inspection of Electro-Cap’s facilities.