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 reasonably related will not be approved until such violations have been corrected. This new warning signal is truly significant, since the FDA had already sent a warning letter to Rubinstein. The FDA's Staff visited the company premises a year before. In the recent letter, they highlighted that their previous noted violations remain uncorrected. The agency listed a long list of faults under the signature of the Director Robin Newman.
Finally, through this warning letter, a written communication was requested regarding the specific measurements to correct the observed violations, including a description of the steps to be followed in order to prevent these or similar violations. This communication shall also include documentation of the corrections and/or corrective actions that the firm has taken. If the firm's planned corrections and/or corrective actions occur over time, they have to submit a timetable for completing the implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, the company shall state the arguments for the backlog and include the time within which these actions will be completed. Moreover, a translation of documents that are not in English must be provided to facilitate their review.
Other recipients of the warning letters were five manufacturers of devices located in the UK, three in China, two in Germany, one in France, one in Italy and one in the Philippines.
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