• Brazil Expedites Device Imports

    Brazil's national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing site is granted a Certificate of Good Manufacturing Practices (CBPF) by a foreign regulator.  Under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the ...
  • 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...
  • FDA Finds 'Significant' Problems at API Manufacturer

    Two facilities maintained and run by a manufacturer of active pharmaceutical ingredients (API) exhibited serious violations of current good manufacturing practices (CGMPs), the US Food and Drug Administration (FDA) said in a Warning Letter issued this week . The API manufacturer, CBS Chem , was subject to two separate inspections in 2013, one for its facility in Tempe, AZ and another for its Tuen Min, Hong Kong facility. Arizona While FDA inspectors alleged that both...
  • Woodcock to Legislators: FDA Has Limited Role to Play in Advancing Manufacturing

    What role does the US Food and Drug Administration (FDA) have to play in promoting advanced manufacturing in the United States, if any? Manufacturing Hearing In a 12 December 2013 hearing before the House Committee on Oversight and Government Reform, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), argued that while manufacturing may be shifting overseas, the factors behind those moves have less to do with FDA than with market-driven...
  • Paintbrush, Cardboard and Black Residue Earn Supplement CMO a Warning Letter

    One week after logging a record low for posted Warning Letters-that is, zero posted-the US Food and Drug Administration (FDA) is back in action, logging a normal, if slightly higher, number of letters. And at least one of those letters shows rampant and disturbing violations at a dietary supplement manufacturer's facility. The letter to New Jersey-based DNE Nutraceuticals, a self-described contract manufacturer, references a lengthy inspection conducted by FDA between 19...
  • Trust but Verify: Supplement Manufacturer's Reliance on Trust not Sufficient to Meet CGMPs, Says FDA

    Trust is the foundation of many good relationships, but as a new Warning Letter to a dietary supplement manufacturer illustrates, it's not the foundation of a good manufacturing practices (GMP) system. The 15 April 2013 letter to Irenda Corporation of Los Angeles, CA, references a September 2012 inspection during which FDA inspectors reportedly found "significant violations" of current GMP regulations for dietary supplements under 21 CFR 111. The reported violations we...
  • After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ

    In February 2013, the US Department of Justice (DOJ) announced it would be making the enforcement of the US Food and Drug Administration's (FDA) current good manufacturing practices (CGMPs) one of its "top areas of focus" for 2013. And while the ultimate effects of that effort have yet to be realized, at least one pharmaceutical manufacturer is now feeling the brunt of DOJ's enforcement activities. Bad Inspections In a 26 August 2013 announcement, DOJ said it has file...
  • New Warning Letters to Indian Manufacturers Again Find CGMP Violations, Falsified Test Results

    Another batch of Warning Letters made public by the US Food and Drug Administration (FDA) has brought still more negative attention toward Indian pharmaceutical manufacturers, with issues that mirror recent letters and include falsification of records and failure to assure product sterility. Background Indian manufacturers have been the focus of intense scrutiny in recent months following a major court case involving Indian manufacturer Ranbaxy, in which it pleaded gu...
  • DIY Fixes Don't Meet CGMP: FDA Slams Manufacturer for Fixes Involving Tape, Rubber Bands

    Do-it-yourself fixes are a point of pride for many, from knowledgeable handymen to frugal college students. Gutters on your house leaking? Nothing some tack welding can't fix. Rubber hose in your car sprung a leak? A quick patch with some duct tape will do in a pinch. But as a new Warning Letter from the US Food and Drug Administration (FDA) to a dietary supplement manufacturer illustrates, shoddy DIY isn't compatible with current good manufacturing processes (CGMP). Ru...
  • FDA Cracks Down on Indian Manufacturers, Citing New FDASIA Authority and Egregious Violations

    In the wake of a disturbing regulatory investigation against Indian manufacturer Ranbaxy, in which regulators determined that the company had routinely falsified and altered testing results-determinations that later resulted in a massive $500 million fine against the company, the largest in history-the US Food and Drug Administration appears to be cracking down hard on other Indian manufacturers for similar discrepancies. The Start of a Crackdown? The first hint of th...
  • Warning Letter to Wockhardt Details Extraordinary Failures, Efforts to Deceive FDA Inspectors

    Indian pharmaceutical manufacturer Wockhardt has not had an easy few months. A March 2013 inspection by the US Food and Drug Administration (FDA) resulted in an import alert for products manufactured at the company's Waluj, Aurangabad facility, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a massive recall for products manufactured at the same facility. Clearly, something at the facility was amiss-something confirmed by the India Times ...
  • Global Networks Lead to Global Scandal as MHRA Defends Against Questionable Ranbaxy Practices

    For years, regulators around the globe have been touting the challenges and benefits of globalization, explaining that a globally diverse product supply chain means needing to rely on regulatory partners to ensure that products are safe for consumption. Now UK regulators are learning a related lesson: A scandal that affects products intended for one country may well affect more than just one regulatory authority. Background On 13 May 2013, Ranbaxy Laboratories pled gui...