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  • Regulatory NewsRegulatory News

    Texas Firm Draws FDA Warning Over Adulterated Device

    In a new US Food and Drug Administration (FDA) warning letter, Plano, TX-based Surgisil was urged to come into compliance with the marketing of its Perma Facial Implant over an unapproved intended use. FDA conducted an inspection of Surgisil’s operations, including its website , last September and determined the firm had been marketing the Perma Facial Implant for augmentation of the lips. The device obtained 510(k) clearance for “cosmetic augmentation and correction...
  • Regulatory NewsRegulatory News

    Drug Counterfeiters Could Get Life in Prison Under New Bill

    New legislation introduced in the US House of Representatives just prior to the holiday break would amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to increase penalties on the sale or trade of counterfeit pharmaceuticals and also grant the US Food and Drug Administration (FDA) new authority to recall drugs. Counterfeit Bill Proposed The proposed legislation, The Counterfeit Drug Enforcement Act of 2014 , was introduced on 11 December 2014 by Rep. Steve Is...
  • Regulatory NewsRegulatory News

    Enough Horsing Around: FDA Warns Four Companies Over Equine Ulcer Drugs

    Three marketers of equine drugs have been warned by the US Food and Drug Administration (FDA) this week, all for allegedly marketing their products without first receiving approval from federal regulators. The three companies— Tri-Star Equine , HorsePreRace and Horse Gold, Inc —are all accused by FDA of marketing their products in ways that cause them to be "intended for use in the mitigation, treatment or prevention of disease in animals." As with their human equival...
  • Regulatory NewsRegulatory News

    FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections

    The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections. Background In July 2013, FDA released a draft guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection seeking to clarify its newfound authority under the Food and Drug Administration Safety and Innovation Act (FD...
  • Regulatory NewsRegulatory News

    Manufacturer of Viagra-Laced Supplements Tried to Hide Records from FDA, Agency Claims

    In one of the most unusual Warning Letters sent by the US Food and Drug Administration (FDA) this year, a dietary supplement manufacturer has been chided by regulators for allegedly failing to allow an inspector to fully inspect the facility, allegedly because the products manufactured there contained an active ingredient also contained in Pfizer's Viagra. Background As recounted in FDA's 26 September 2014 Warning Letter, FDA inspectors arrived at Pennsylvania-based Nov...
  • Regulatory NewsRegulatory News

    Final Regulation Makes it Easier for FDA to Seize Drugs at the Border

    The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded. Background The rule is borne from the  Food and Drug Administration Safety and Innovation Act (FDASIA) , Section 709 ("Administrative Detention") of which ordered FDA to promulgate a final regulation within two years of the passage...
  • APEC Moving Toward 'Regulatory Convergence' in Effort to Safeguard Drugs, Improve Manufacturing

    An international organization which counts most of Asia as members says it and its members will be committing to a joint, multi-year initiative intended to improve medical product manufacturing and the security of the medical product supply chain. In an announcement on 12 May 2014, the Asia-Pacific Economic Cooperation (APEC) group said its membership had committed to a "greater alignment of policies safeguarding pharmaceuticals, medical devices and biomedical goods"-a c...
  • Warning Letter Analysis: Siemens, Terumo Cited for Adulterated Devices

    • 20 June 2012
    The US Food and Drug Administration (FDA) sent warning letters in May 2012 to Siemens Healthcare Diagnostics, Inc and Terumo Medical Products Hangzhou Company Ltd accusing the companies of manufacturing adulterated products in violation of federally mandated Quality System Regulations (QSRs). For one of the companies, the warning letter effectively bars its products from being imported into the US. Siemens Healthcare Diagnostics, Inc. (Medical Device) In its 10 May ...
  • Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies

    • 30 May 2012
    The US Food and Drug Administration's (FDA) newest batch of warning letters was released on 29 May 2012, and some familiar faces have come under further scrutiny. Medical device manufacturer McNeil PPC, a subsidiary of Johnson & Johnson, was hit with a lengthy list of claims by FDA, which said the firm is manufacturing no fewer than ten adulterated products. Three of the company's Pennsylvania facilities are currently the subject of an FDA consent decree after the...
  • USP Plans to Launch Updated Heparin Standard to Ensure Safety

    • 23 May 2012
    The US Pharmacopoeia (USP) is announcing the impending launch of an updated standard meant to further boost the safety and quality of Herparin, contaminated supplies of which were associated with numerous deaths in 2007 and 2008.  "The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality," said USP in a statement. "In response to reque...
  • Warner Chilcott Warned by FDA for CGMP Violations in Birth Control Product

    The US Food and Drug Administration (FDA) sent pharmaceutical manufacturer Warner Chilcott a warning letter 8 March for perceived violations of current good manufacturing practices (cGMPs) at their Fajardo, Puerto Rico plant. In the letter, FDA notes pharmaceuticals manufactured at the plant were adulterated as a result of staff failing to investigate batch failures and out-of-specification components. Further, the plant was unable to verify whether adulterated batches h...