Since we last reported on enforcement actions in December 2014,
FDA posted warning letters to drug and device manufacturers, as
well as one fertility center, for violations related to CGMP
("Current Good Manufacturing Practices"), QSR
("Quality Systems Regulations"), MDR ("Medical
Device Reporting"), selling unapproved animal drugs, clinical
investigations, and deviations from the regulations for human
cells, tissues, and cellular and tissue-based products.
FDA continues to cite medical device manufacturers for CGMP and
QSR violations, including those related to design change
procedures, complaints handling, process controls, corrective and
preventative action procedures, and maintaining device master
records. Recipients of these warning letters, three of which are
located overseas, included manufacturers of coronary bypass
cannulas, endoscopes, portable oxygen generators, gas flow
regulators, peripheral vascular testing devices, therapeutic
infrared heating lamps, neuromuscular stimulators, acupuncture
needs, slings, incontinence mesh, and dental devices. Six medical
device manufacturers, three of which are located abroad, were also
warned for failure to follow the MDR regulations. Two medical
device manufacturers, one located abroad, were cited for marketing
medical devices without the necessary marketing clearance or
approval. One of the firms had obtained clearance for its device
but was promoting the device beyond the scope of its intended use
without submitting a new premarket notification.
Drug manufacturers continue to receive warning letters for CGMP
violations, as well as misbranded or unapproved drugs. CGMP
violations include those related to preventing contamination and
maintaining a sterile environment. FDA additionally warned an
active pharmaceutical ingredient manufacturer in China for CGMP
violations. A Mexican drug manufacturer was also warned for failing
to pay required Generic Drug User Fee Amendments fees.
FDA continues to monitor compounding pharmacies. One such pharmacy
was warned after FDA received reports of adverse events in patients
who used the pharmacy's products. 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.
FDA cited a clinical investigator for failing to properly maintain
case histories and for failing to ensure the investigation adhered
to the investigational plan. A fertility center received a warning
letter for deviations from the relevant regulations for human cells
and tissues, including failure to collect and screen donor
specimens for relevant communicable diseases.
Finally, FDA posted one warning letter to a veterinary company
that sells animal drugs online for marketing an unapproved new
animal drug, and another warning letter to a dairy operation for
using a veterinary drug beyond what was directed by the drug's
approved labeling.
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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