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  • Regulatory NewsRegulatory News

    Power Failures Land India-Based Cancer API Manufacturer a Form 483

    Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...
  • Regulatory NewsRegulatory News

    FDA Hands Akorn 483 Over GMP Issues at New Jersey Site

    In an inspection report released Friday, the US Food and Drug Administration (FDA) details 11 observations from an inspection of Akorn’s Somerset, New Jersey facility in July and August of this year.   This is the second Form 483 Akorn has received in 2018. In May the company was handed a Form 483 listing a total of 13 observations from an inspection of the company’s Decatur, IL facility, the third inspection report issued for that facility in three years.   Form ...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • Regulatory NewsRegulatory News

    FDA Finds Quality Documents Stuck in a Shredder at Glenmark Facility

    The US Food and Drug Administration (FDA) on Tuesday released a heavily redacted Form 483 sent last month to Glenmark Pharmaceuticals' Solan, India-based manufacturing facility. One of the seven observations in the Form 483, first announced by the company on 28 November , noted that FDA inspectors found at least 13 quality documents "shredded in the teeth and surrounding internal moving parts of the shredder." FDA said the quality documents were not listed on the ...
  • Regulatory NewsRegulatory News

    Updated: FDA Form 483 for Celltrion Site Manufacturing Remicade Biosimilar

    The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US, though Pfizer says the limited uptake has more to do with Johnson and Johnson's exclusionary contracts. The Form 483 for the Incheon, Korea-base...
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    EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

    The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). The update, drafted in July 2015 , comes as there has been an increasing trend toward the outsourcing of manufacturing and more complex supply chains. The guideline "does not introduce new requirements" on authorized drugs, though t...
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    FDA: Lead Test Company May Have Violated Federal Law

    The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems. FDA cited the issues in a 10-page inspection report stemming from a month-and-a-half long inspection of Magellan's North Billerica, MA facility from 10 May to 29 June 2017. A week into that inspection, FDA warned the public that all four of Magel...
  • Regulatory NewsRegulatory News

    New FDA Warning Letter, Form 483 for Two Indian Companies

    The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic drugmaker Aurobindo Pharma. Warning Letter: Sal Pharma FDA's warning to Sal Pharma comes roughly 10 months after the agency inspected the company's Hyderabad, India facility in June and July 2016. Last February, the agency placed the firm on import alert . According to the warnin...
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    FDA Issues Form 483 for Lupin's Goa Facility

    The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month. The Form 483 details three observations made by FDA investigators during an inspection conducted 27 March–7 April 2017, and comes roughly a year after the company reported receiving nine observations from an earlier inspection of the facility. According to Lupin's website , the...
  • Regulatory NewsRegulatory News

    A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers

    As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports. Thanks to the Freedom of Information Act, Focus obtained from FDA two lists detailing not only the 86 requests for the Form 483s issue...
  • Regulatory NewsRegulatory News

    FDA Form 483 Cites 14 Observations for Zimmer Biomet

    Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Detroit-based site with 14 observations. The 58-page, heavily-redacted Form 483 follows the site inspection from 12 September 2016 to 22 November 2016. The first observation – on sterilization validation and a “test that has not been adequately validated” – and the seven...
  • Regulatory NewsRegulatory News

    FDA Sends Form 483 to Sterile Manufacturer Akorn Pharmaceuticals’ Illinois Plant

    The US Food and Drug Administration (FDA) on Tuesday released a Form 483 (which can be the precursor to a warning letter) with six observations to one of two Akorn Pharmaceuticals’ Decatur, Illinois-based sterile drug manufacturing facilities. The observations were uncovered during a 10-day inspection in June and include quality control issues, unrecorded or unjustified deviations from written production and process control procedures, quality control responsibilities an...