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,
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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