• Regulatory NewsRegulatory News

    FDA Warns Taiwanese Drug Manufacturer Over Significant cGMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter for Taiwanese drug and contract manufacturer Ko Da Pharmaceutical over four specific violations. The letter from FDA’s Center for Drug Evaluation and Research, sent 27 May, revealed the following significant violations of current good manufacturing practice (cGMP):  Ko Da’s quality control unit failed to approve or reject all procedures or specifications impacting the identity, strength...
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    Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance

    The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ensure data is consistent and accurate. The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records, as well as re...
  • RAPS' LatestRAPS' Latest

    FDA Expresses Desire to Work With Industry on CGMPs for Combo Products

    During RAPS’ and the Combination Products Coalition’s (CPC) recent workshop on current Good Manufacturing Practice (CGMP) for combination products, which took place on 1 April, the US Food and Drug Administration’s (FDA) lead presenter, John Barlow “Barr” Weiner, paused briefly to acknowledge the date’s popular connotation. “I just realized I should’ve inserted some sort of April fools [joke] in this presentation,” said Weiner, who is the associate director for polic...
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    Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns

    A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be altered or falsified—claims similar to those levied against many Indian pharmaceutical companies. In a 27 February 2015 Warning Letter to Novacyl Ltd, FDA references an April 2014 inspection of the company's Samukprakam, Thailand manufacturing facility. There, FDA said it "identifi...
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    How do you Ensure the Proper Manufacture of a Combination Product? FDA Explains

    New guidance issued by the US Food and Drug Administration (FDA) offers an extensive set of recommendations on how members of the pharmaceutical industry can comply with a rule regarding the proper manufacture of combination products. Background Combination products are, as their name implies, a combination of two or more product classes, such as a medical device, biologic and a pharmaceutical product. They are typically regulated by analyzing their constituent parts to...
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    FDA Warns Indian Generics Manufacturer Cadila Over Data Integrity Issues

    The US Food and Drug Administration (FDA) has issued a stern warning to the Indian pharmaceutical manufacturer Cadila regarding various deficiencies at its drug production facility in Ahmedabad, including serious problems with the systems needed to ensure testing data isn't falsified. Background The letter to Cadila is the 13th sent by FDA to an Indian pharmaceutical company regarding so-called "data integrity" issues since May 2013. For a complete listing, ple...
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    India’s CDSCO Issues Guidance on How to Conduct GMP Inspections

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 6 August 2014 to all local State Drugs Controllers setting forth uniform procedures on how to conduct good manufacturing practice (GMP) inspections of local pharmaceutical manufacturing facilities....
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    After Six-Month Dry Spell, FDA Finally Sends Warning Letter to Chinese Company

    Unless you've been paying close attention, you'd be forgiven for missing one of the biggest stories at the US Food and Drug Administration (FDA) this year. While the agency has been sending letter after letter to manufacturers in India, until this week the agency hadn't sent a single Warning Letter to a company in China—a curious trend following the 38 sent to Chinese companies since 2008 and the six it sent to them last year alone. Background The lapse in Warnin...
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    Regulators Again Find Data Integrity Problems at Indian Manufacturing Site

    Nearly three months after Canadian generics firm Apotex was put on import alert by the US Food and Drug Administration (FDA), the agency has released the text of a Warning Letter issued to the company, highlighting alleged practices that led to some of the firm's products being banned from the US. Background Apotex has been the recipient of three FDA Warning Letters , which indicate major deficiencies and threaten further action by regulators, since 2009. All th...
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    Sterility Concerns Lead to Warning Letter, Import Alert for German Pharmaceutical Manufacturer

    The US Food and Drug Administration (FDA) has sent a Warning Letter to German-based pharmaceutical manufacturer SANUM-Kehlbeck GMbH & Co alleging that it violated current good manufacturing practices (CGMP) at its Hoya, Germany facility. The company also failed to register its facility with US regulators in violation of Section 510 of the Federal Food, Drug and Cosmetic Act (FD&C Act) , FDA charged in its 11 April 2014 letter to the company , released today. The bulk...
  • Warning Letter to Allergy Manufacturer Cites Insects, Unapproved 'Custom Mixes'

    A new Warning Letter from the US Food and Drug Administration (FDA) to North Carolina-based allergy product manufacturer Greer Laboratories claims that the company failed to manufacture an allergenic extract in the manner described in its approved biologics license application (BLA), among other alleged problems. The 21 April 2014 Warning Letter-released to the public on 6 May 2014-references a November 2013 inspection by FDA officials at Greer's Lenoir, NC facility. Th...
  • "Our Lady's Tears" Brings Warning Letter to Supplement Maker

    If you didn't know better, seeing an ingredient on a dietary supplement labeled as "Our Lady's Tears" might make you think the manufacturer's process involved forcing a woman to cry into a batch of ingredients destined for further processing. And that, the US Food and Drug Administration (FDA) explained in a Warning Letter recently posted on its website, is a problem-for the manufacturer, that is. FDA's 21 March 2014 Warning Letter to Florida-based Aloe Man Internation...