FDA Focuses On Argentinian Medical Devices

In May 2016, FDA sent the second warning letter to the Argentinian manufacturing medical device company. The FDA has sent letters to 14 different medical device manufacturers around the world, including the Argentinian F.P. Rubinstein and Co. from Córdoba Province as the only Latin American company.

In March 2016, the Argentinian Ministry of Health (ANMAT) issued the Good Manufacturing Practice certificate to this company for in vitro diagnostic medical devices. However, the FDA determined that the Good Manufacturing Practices have not been applied.

The FDA's warning letter of May 2016 was a result of the inspection conducted in December 2015 in the Rubinstein's Factory located in Córdoba, Argentina. "This inspection revealed that these devices, laser-powered surgical instruments, are adulterated due to the fact that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current Good Manufacturing Practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.", FDA.

These violations include, but are not limited to, the following: "Failure to establish and maintain procedures for implementing corrective and preventive action; failure to establish and maintain procedures for validating the device design; failure to establish and maintain procedures to control environmental conditions, where they could reasonably be expected to have an adverse effect on product quality and failure to maintain device history records, among others".

Consequently, according to the FDA, US federal agencies have also required to be notified of the issuance of warning letters so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class Ill devices to which the Quality System regulation deviations are...