The FDA today released a warning letter it sent to Berwickshire Electronic Manufacturing detailing issues with the firm’s manufacturing processes and barring the products from importation into the U.S.
Berwickshire Electronic Manufacturing produces the Helica Thermal Coagulator and Helica LT/LTC probes, which are electro-surgical devices designed for treating endometrioses.
The federal watchdog noted 9 different infractions, ranging from product conformity control to failures to maintain device master records, with 24 specific points for the company to fix.
Berwickshire were pegged multiple times by the FDA for issues associated with quality verification procedures, both for products they produce, products used for production and products shipped from the company’s facilities.
On a major tick, the federal watchdog said that the company was failing to “ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results,” according to the warning letter.
The federal watchdog didn’t pull punches with the inspection stating that “given the serious nature of the violations of the Act, the devices manufactured by your firm, including the Helica Thermal Coagulator and the Helica LT/LTC Probes, are subject to refusal of admission.”
The FDA said that the devices would be refused entry into the U.S., facing “detention without physical examination” until the violations are corrected.
The agency also said that it U.S. federal agencies would be advised that the company had received warning letters, which may be taken into account when awarding contracts.
Berwickshire was given 15 business days to respond to the warning letter.