RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Updated FDA Manual Offers Inside Look at Inspection Protocols

    The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect. The 127-page chapter offers the basics for how FDA inspectors should go about conducting what it calls, a "careful, critical, official examination of a facility to determine its compliance with laws administe...
  • Regulatory NewsRegulatory News

    Chinese Heparin Contamination Questions Return With New FDA Warning Letter

    The US Food and Drug Administration (FDA) released a warning letter on Wednesday for China-based heparin contract testing lab, Shandong Analysis and Test Center, reigniting a debate over whether the questionable sources of heparin that led to almost 100 American deaths a decade ago have been rooted out. Background In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths, though House Energy & Commerce committee members expressed co...
  • Regulatory NewsRegulatory News

    FDA to Drug Manufacturers: Beware Water-Borne Contaminants

    With a crop of recent product recalls due to Burkholderia cepacia complex (BCC) contamination, the US Food and Drug Administration (FDA) on Monday warned drug manufacturers of non-sterile, water-based drug products of the dangers that BCC and other water-borne opportunistic pathogens pose. “BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents,” FDA said in a stat...
  • Regulatory NewsRegulatory News

    How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains

    During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories. The 12-page guidance, first proposed in January 2015, notes that the risk of cross-conta...
  • Regulatory NewsRegulatory News

    Compounders Beware: API from China May Be Contaminated, FDA Says

    The US Food and Drug Administration (FDA) late Wednesday released a warning for drug compounders that certain lots of the active pharmaceutical ingredient (API) baclofen, manufactured by China’s Taizhou Xinyou Pharmaceutical & Chemical Co., may be at risk for contamination. “FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in inje...
  • Regulatory NewsRegulatory News

    FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants

    The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed. "We concur with Sientra’s recommendations to take a cautionary approach until more is known, and we are actively working with the company and other international regulators to investigate the issue. The FDA is in close c...
  • Regulatory NewsRegulatory News

    After Investigation Reveals Deadly Flaws, FDA Issues Warnings About Duodenoscopes

    US regulators have issued a warning to healthcare providers about design flaws inherent in a type of endoscope which could increase the spread of harmful infections in surgery patients. Background The device, known as an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, is a flexible, lighted tube commonly used in surgical procedures to inject contrast dye or to obtain tissue samples. "Unlike most other endoscopes, duodenoscopes also have a movable '...
  • As Medical Marijuana Hits Mainstream, Regulators Take Notice With Safety Recalls

    In the US, states are increasingly squaring off against federal regulators in an attempt to grant their citizens access to medical marijuana, which advocates argue can provide pain relief to patients afflicted with cancer or other painful conditions. But north of the US border, where medicinal marijuana is legal when authorized by a doctor or nurse practitioner, Canadian regulators are grappling with another marijuana issue entirely: The recall of medicinal marijuana due...
  • FDA Warning Letter Hits GSK for Contaminated API, Reproducibility Challenges

    A new Warning Letter sent to GlaxoSmithKline CEO Andrew Witty chides the company for alleged manufacturing deficiencies found by US Food and Drug Administration (FDA) inspectors at the company's manufacturing subsidiary in Cork, Ireland. That subsidiary, SmithKline Beecham (Cork) Ltd., is a manufacturer of active pharmaceutical ingredients (API) for GSK. During an October 2013 inspection, FDA said its inspectors found at least three major problems that caused the facilit...
  • Compounding Pharmacy Recalls all Products after FDA Finds Microbial Contamination in Vials

    The US Food and Drug Administration (FDA) has announced that yet another compounding pharmacy has initiated a national recall for all products manufactured at a Florida facility, explaining that an inspection of the facility last month found deficient practices that might have exposed its sterile products to microbial contamination. Background Compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without havi...
  • FDA Inspectors Find Insects, Animal, Contamination at Compounding Facility

    Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis. The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 release...
  • Chronic Regulatory Compliance Issues Causing Shortages, Safety Problems

    • 18 October 2012
    Chronic regulatory lapses at manufacturing facilities are exacerbating drug shortages and patient safety issues, claims a new report published in The New York Times . The report chronicles the huge number of issues-some of them particularly egregious-that have occurred in recent years at facilities responsible for manufacturing pharmaceutical products. The problem is especially prominent at facilities that manufacture sterile injectable drugs, which have experienced...