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  • 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...
  • Warning Letter Analysis: FDA Asks for Notification of Impending Drug Shortages in Newest Citations

    • 23 May 2012
    The US Food and Drug Administration (FDA) released a new batch of warning letters on 23 May, citing two pharmaceutical manufacturers and two medical device manufacturers for a series of regulatory infractions including current good manufacturing practice (CGMP) deficiencies, adulterated products, quality system regulation deficiencies and sterility issues. In a new development, FDA is also asking for companies served with warning letters to keep in informed about future ...
  • Pfizer Recalls 653,000 Bottles of Advil After CGMP Deficiencies Cause 'Strong Odor'

    • 21 May 2012
    New York-based pharmaceutical manufacturer Pfizer has recalled more than 653,000 bottles of its Advil Liqui-Gels pain-reliever after becoming aware of a "strong odor" in the product, reports Dow Jones Business Wire . The products, composed of eight lots manufactured at an Argentina-based facility operated by contract manufacturing organization (CMO) Catalent Argentina S.A.I.C., were recalled from retail-distribution centers in March, according to a US Food and Drug Admi...
  • Warning Letter Analysis: Companies hit for CGMP, Reporting Violations

    • 17 May 2012
    The US Food and Drug Administration (FDA) released three warning letters on 17 May 2012 previously issued to companies in the healthcare product sector, including two pharmaceutical manufacturers and one blood products supplier detailing current Good Manufacturing Practices (cGMP) and adverse event reporting violations. Selder S.A. de C.V. (Pharmaceutical) A warning letter sent to Selder S.A.'s Director General and Owner, Alejandro Villarreal, by FDA identifies n...
  • CGMP Violations Could Lead to Three Years in Jail for Former Medical Device Executive

    The US Food and Drug Administration's (FDA) Office of Criminal Investigations and the US Department of Justice (DOJ) have announced the indictment of William Zinnanti, the former President and Owner of Zinnanti Surgical Design, for selling devices to hospitals in violations of current Good Manufacturing Practices (cGMPs). According to a 15 May statement released by DOJ, Zinnanti Surgical Design manufactured a non-sterile surgical device used primarily in hospital setting...
  • Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, CGMP, Design Deficiencies

    The US Food and Drug Administration (FDA) released five warning letters previously issued to companies in the healthcare product sector, including three medical device companies, one pharmaceutical distributor and one supplement manufacturer. William Demant Holdings A/S (Medical Device) FDA's warning letter to William Demant , a Danish medical device manufacturer, cited deficiencies at its Oxford, UK facility found during two December 2011 inspections. The company, w...
  • Brazil: New Agreement Paves Way for Manufacturing Facilities to Produce Multiple Drug Types

    Based on a 7 May agreement between Brazil's National Health Surveillance Agency (ANVISA) and the Ministry of Agriculture, Livestock and Supply (MAPA), companies will be allowed to produce drugs for both veterinary and human use in the same manufacturing facility as long as the active ingredients and excipients have been approved for both human and veterinary use. Companies wishing to take advantage of this new approach will be required to obtain Certificates of Good Ma...
  • Agency Increasing Number of Supplement Inspections, Says Fabricant

    The number of inspections conducted by the US Food and Drug Administration (FDA) is increasingly rapidly as the agency moves to crack down on violators of quality regulations, the Director of FDA's supplement program said, reports Natural Products Insider . Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs, said the agency is starting to use its authorities more aggressively-something Regulatory Focus took note of in April 2012 and May 2...
  • FDA Cites Military-tech Company for Marketing Medical Device Without Approval

    A company marketing several medical devices intended to be used in combat situations has been cited by the US Food and Drug Administration (FDA) for marketing one without having sought approval from the agency and manufacturing numerous others in violation of current good manufacturing practices. In a warning letter released 9 May, FDA said Virginia-based manufacturer H&H Associates does not have "an approved application for premarket approval in effect" pursuant to ...
  • FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers

    The US Food and Drug Administration's (FDA) top dietary supplement regulator said at an industry conference meeting he is " aghast at the degree of non-compliance " when it comes to current good manufacturing practices (cGMPs) and adverse event reporting (AER) in the industry, reports Nutra Ingredients USA . Speaking 25 April to a meeting convened by the Natural Products Association, Daniel Fabricant, director of FDA's Dvision of Dietary Supplement Programs, said the in...
  • Company Cited for Failure to Follow Numerous Medical Device cGMP Regulations

    • 25 April 2012
    A warning letter released to the public 23 April cites medical device manufacturer Ad-Tech Medical Instrument Corporation for failure to follow medical device regulations established by the US Food and Drug Administration (FDA). The company, which manufactures devices for neurological monitoring and neurosurgery, was hit with a bevy of regulatory citations by FDA, which noted  the company's products were "not in conformity with the Current Good Manufacturing Practic...
  • FDA Releases New CGMP Labeling Provisions for Drug Products

    The US Food and Drug Administration (FDA) is making changes to the packaging and labeling control portions of the current good manufacturing practice (CGMP) regulations for drug products, the agency announced in the Federal Register . In its 19 March posting, FDA said it would limit "the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that a...