Since we last reported on enforcement actions in January 2015,
FDA posted warning letters to drug and device manufacturers for
violations related to CGMP ("Current Good Manufacturing
Practices"), QSR ("Quality Systems Regulations"),
and MDR ("Medical Device Reporting"). The amount of
warning letters declined compared to when we last reported in
January 2015, with only four warning letters sent to medical device
manufacturers and three to drug manufacturers since our last
Update.
FDA continues to cite medical device manufacturers for CGMP and
QSR violations, including those related to device designs,
maintaining device master records, complaint procedures,
post-sterilization inspections, and device packaging and shipping
containers. Recipients of these warning letters included
manufacturers of in vitro diagnostic devices, intravenous tubing
sets, and convenience packs for surgical procedures. One medical
device manufacturer was also warned for failure to follow the MDR
regulations and for marketing medical devices without the necessary
marketing clearance or approval.
Drug manufacturers continue to receive warning letters for CGMP
violations as well as misbranded drugs. CGMP violations include
those related to preventing contamination, maintaining a sterile
environment, and ensuring laboratory records included complete
data. One manufacturer was also cited for failing to submit field
alert reports within three working days of receipt of information
concerning any significant change or deterioration in a distributed
drug product.
FDA continues to monitor compounding pharmacies. One such pharmacy
was warned after investigators noted that the pharmacy was not
receiving valid prescriptions for individually identified patients.
The compounding pharmacy was cited for practices that render the
pharmacy ineligible for statutory exemptions from the laws that
generally apply to drug manufacturers. The compounding pharmacy was
additionally cited for violations relating to insanitary conditions
and CGMP.
View FDA's Warning Letters homepage (scroll
down for listing of recently posted Warning Letters).
The Office of Prescription Drug Promotion ("OPDP") has
issued no new warning letters since the last Update.
View a complete listing of 2014 OPDP Warning
Letters.
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