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  • Regulatory NewsRegulatory News

    FDA Warning Letter Reveals Data and Sterility Issues at Teva Plant in Hungary

    The US Food and Drug Administration (FDA) on Tuesday released the warning letter it sent to Israel-based Teva Pharmaceuticals earlier this month, noting instances of data deletion and manipulation at the company’s manufacturing site in Gödöllő, Hungary. Last week, Teva disclosed in an SEC filing that it had received a warning letter on 14 October (four months after the site was banned from shipping products to the US), but now the details of that letter have revealed...
  • Regulatory NewsRegulatory News

    Massive Recall of Medical Devices Largest Ever Recorded by FDA

    A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA. Background: Recall Trends The devices, which were manufactured by Puerto Rico-based device manufacturer Customed, Inc, were given a Class I recall classification —FDA's most serious recall classification, given to those devices in cases where "there is a reasonable probability t...
  • FDA Announces Bevy of Sterility-Related Recalls

    The US Food and Drug Administration's (FDA) MedWatch staff had an unusually busy 6-8 September 2013 weekend, announcing the recall of products from three companies due to serious problems that could potentially affect patient safety. The Return of Recalls for McNeil One of the three companies is McNeil Consumer Healthcare, a Johnson & Johnson subsidiary that has conducted a number of high-profile recalls of many widely available products in recent years, including...
  • Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections

    What did government officials know, when did they first know it, and what did they do in response? It's a classic question faced by nearly every agency in the US government, including the US Food and Drug Administration (FDA), which has in recent months been under pressure from legislators regarding its oversight of the pharmaceutical compounding industry. In light of a massive outbreak of fungal meningitis that has since been linked to products manufactured at a Massach...
  • Compounded Products Linked with Potential Deadly Infections, Putting New Pressure on FDA, Congress

    A steady drumbeat of recalls related to potentially non-sterile products manufactured at compounding pharmacies continues, with the US Food and Drug Administration (FDA) issuing announcements this weekend that Specialty Compounding LLC was recalling "all lots of sterile medications within expiry" after at least 15 patients experienced bacterial infections after being given the medication. Background FDA regulates pharmaceutical compounders differently than traditional m...
  • FDA Testing Confirms Fungal, Bacterial Contamination of Yet Another Pharmacy's Products

    US Food and Drug Administration (FDA) officials yesterday confirmed what they have feared for more than a week: Products from yet another pharmaceutical compounding pharmacy are contaminated with fungal and bacterial growth. Background Compounding pharmacies have been subject to enhanced scrutiny by FDA in recent months, resulting in a huge number of Warning Letters, Form 483s, recalls and general warnings to consumers and healthcare providers. The root of this enhance...
  • Disturbing Parallels Seen in New Compounding Pharmacy Warning

    US regulators have issued a warning regarding products compounded at a Tennessee pharmacy, saying that it was aware of at least seven adverse events potentially associated with supposedly sterile steroid injectable products manufactured by the company, drawing close parallels to an outbreak that occurred in October 2012. Background Compounding pharmacies have been subject to enhanced scrutiny by FDA in recent months, resulting in a huge number of Warning Letters, Form 4...
  • Compounding Pharmacy Recalls Continue as FDA Inspection Finds Still More Deficiencies

    A steady drumbeat of recalls from compounding pharmacies has struck a note for the third time in approximately a week, with Massachusetts-based Pallimed Compounding Pharmacy issuing a notice indicating that all sterile products manufactured at the facility should be recalled and not used after an inspection by the US Food and Drug Administration (FDA) indicated deficiencies. In a statement, the company said it had not been made aware that any compounded product made by i...
  • Sterility Violations Form Basis of FDA Warning Letter to Novo Nordisk

    Life sciences manufacturer Novo Nordisk has been sent a Warning Letter from the US Food and Drug Administration for what regulators said were "significant" deficiencies found at the company's Bagsvaerd, Denmark facility. FDA officials said they were particularly concerned about current good manufacturing practice (CGMP) violations found at the firm, which included practice deviations that could have potentially led to product being manufactured under non-sterile condit...
  • Alleged Sterility Deficiencies Behind Warning Letter to Medical Device Company

    A warning letter to Atrium Medical Corporation , a new Hampshire-based medical device manufacturer, claims at least four of the company's products are adulterated as a consequence of poor manufacturing practices. The 11 October letter from the US Food and Drug Administration (FDA) cites a number of findings made during the course of an inspection made between 31 July and 7 September. Among the most troubling allegations made by FDA is the systematic failure of steril...
  • FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

    • 23 October 2012
    The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc . after regulators said an inspection found deficiencies that caused the products to be adulterated under federal law. AN calls itself an international, specialist manufacturer of all-natural nutritional supplements. FDA's warning letter, sent 16 October 2012 and published on 23 October, largely concerns violations of federal c...
  • EMA Warns of Potentially Contaminated Cancer Drug in Light of Manufacturing Deficiencies

    Regulators at the European Medicines Agency (EMA) have released the results of an assessment undertaken after an inspection of California-based Pacira Pharmaceuticals uncovered good manufacturing practice violations and sterility issues. The assessment pertains to a single drug, DepoCyte (cytarabine), used to treat patients with lymphomatous meningitis, a rare peripheral cancer affecting the spinal cord and brain tissue. EMA officials said they had inspected Pacira'...