Recent Product Recall
Since the previous Update, FDA issued a recall for injection
products labeled with an incorrect expiration date.
Click here for a complete listing of FDA
Recalls.
Recent Warning Letters
FDA continues to issue letters to medical device manufacturers
for violations of the Quality Systems Regulations, including
in-process sampling and issues related to dealing with
nonconforming product and corrective actions. FDA also warned a
medical device manufacturer for marketing a Class II medical device
without obtaining premarket clearance when the device was not
otherwise exempt or approved.
FDA recently warned a drug compounding facility for insanitary
conditions that led to contaminated products and a drug
manufacturing facility for failure to pay its annual Generic Drug
User Fee. Finally, FDA cited a the sponsor of a medical device
clinical study for violations of the investigational device
exemptions regulations, specifically for issues related to proper
monitoring of the study, informed consent, and failing to notify
FDA that the institutional review board had withdrawn approval of
one of the clinical investigators.
Click here for FDA's Warning Letters Home page
(scroll down for listing of recently posted Warning Letters).
Since the last Update, the Office of Prescription Drug Promotion
("OPDP") issued one warning letter citing a drug maker
for listing unapproved uses and overstating the drug's efficacy
in promotional materials, including educational technique
flashcards and a journal ad. The journal ad in question was also
submitted to the Agency under the Bad Ad Program.
Click here for a complete listing of 2014 OPDP
Warning Letters.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
