These letters are of particular interest to manufacturers of combination products. Recent Trends In Enforcement Activity. Surveying the FDA warning letter database, we learn that there was a 36 percent decrease in the number of warning letters issued by CDRH in 2014 (108) compared to 2013 (169), with most of these issued to domestic manufacturers.
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· FDA tells hospitals that surgical warming blankets OK for use. has said 3M was made aware of the problems with the device before buying its maker.
FDA warns of rare cancer linked to breast implants. In a letter to doctors, nurses and other health professionals, the FDA has issued a warning concerning a rare cancer linked to breast implants.
FDA Nixes Exparel as Nerve Block Drug maker Pacira vows to continue its quest.. Exparel is already indicated for single-dose injection into tissues at the site of surgery to produce post-surgical analgesia.. the FDA sent the company a warning letter, accusing it of overstating both Exparel’s efficacy and its approved indications. Pacira.
CBP Hundreds African Migrants demand entry to US – Ebola Outbreak Map A senior official for Medecins Sans Frontiers (MSF, or Doctors Without Borders) has declared West Africa’s Ebola outbreak "totally out of control." Armand Sprecher, a public health specialist with MSF, said it "is the highest outbreak on record and has the highest number of deaths, so this is unprecedented so far."
Breakdown of FDA Warning Letters. In 2015, FDA issued 121 warning letters to medical device companies, resulting in 690 citations against 21 CFR part 820. Let me dive a bit deeper and breakdown the 2015 warning letter citations according to CFR clause and highlight the top 9 specific areas.
The FDA issued a warning letter to Thermedx, a Solon, Ohio-based manufacturer of gynecological and urological fluid management systems, for failing to notify the agency of device upgrades and other GMP violations.. Validation Issues Top MicroAire Warning Letter. A Virginia maker of implants used in plastic surgery was slapped with a warning.
FDA has sent a warning letter to plastic and cosmetic surgery device maker Surgisil instructing the company to cease marketing two lip implant devices not indicated for that purpose, the agency disclosed Tuesday. Surgisil’s Perma Facial implant is cleared for use in plastic and reconstructive.
At a two-day meeting that starts Monday, a panel of experts for the U.S. Food and Drug Administration will hear from researchers, plastic surgeons. Last week, the FDA sent warning letters to Mentor.
Another 100,000 women receive implants for breast reconstruction after cancer surgery. The panel will hear from researchers, plastic. the FDA sent warning letters to Mentor – a unit of Johnson &.
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