FDA Warns Italian Medical Device Co. of Consequences Unless Violations are Corrected
The Food and Drug Administration issued a warning letter to Italian company BTS S.p.A., which said the FreeEMG and PocketEMG medical devices manufactured by that firm are adulterated because the methods used in, or the facilities or controls used for,…
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their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation. FDA said that, although it previously received a response from the company concerning its investigation, the response was not adequate. According to FDA, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved, and Requests for Certificates to Foreign Governments will not be granted, until the violations have been corrected.