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  • Regulatory NewsRegulatory News

    FDA Warns Datascope Over QSR, Reporting Violations

    The US Food and Drug Administration (FDA) sent a warning letter to New Jersey-based medical device maker Datascope Corporation over quality system regulation (QSR) and medical device reporting (MDR) violations.   Datascope, which was bought by the German multinational Maquet in 2008, markets a variety of cardiovascular devices such intra-aortic balloon catheters and cardiopulmonary bypass tubing packs.   The warning letter comes after an inspection of the company's...
  • Regulatory NewsRegulatory News

    FDA Warns 5 Drugmakers in China, Australia and Austria

    The five warning letters sent from the US Food and Drug Administration (FDA) in December and January and released this week deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs). Shanwei Honghui Daily Appliance  Following an FDA inspection of the Shanwei, China-based facility in July and August, agency inspectors noted “filling machines used to manufacture over the cou...
  • Regulatory NewsRegulatory News

    FDA Warns Imprimis for False and Misleading Website and Twitter Promotions

    The US Food and Drug Administration (FDA) late last month sent a warning letter to San Diego-based Imprimis Pharmaceuticals for false and misleading claims made on the company’s website and Twitter account, among other violations. FDA said that for two products – "Simple Drops" and "Klarity C-Drops" – the company claims they are made with FDA approved components or are FDA-approved, "when that is not the case."  In addition, FDA said Imprimis' website makes false...
  • Regulatory NewsRegulatory News

    FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation

    After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May , the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes. At the outset of the investigation, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said the agency was working to determine the root ca...
  • Regulatory NewsRegulatory News

    FDA Warns Stem Cell Supplier Over Unapproved Treatment

    The US Food and Drug Administration (FDA) on Wednesday warned stem cell product supplier American CryoStem Corporation for marketing an unapproved product after the agency inspected the company's Eatontown, New Jersey site in July. The warning letter comes just months after FDA announced a new framework for regulating regenerative medicines that included a 36-month period of enforcement discretion by the agency, though at the time, an FDA spokesperson told Focus the ...
  • Regulatory NewsRegulatory News

    OPDP Letters: FDA Closes Out 2017 With Record Low

    In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP). The warning letter brings the total number of enforcement letters issued by OPDP in 2017 to four (three warning letters and one untitled letter), a record low for the agency. Whi...
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    FDA Warns Fresenius Kabi API Manufacturing Plant

    The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi's active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies. The warning letter, sent 18 December and following an eight-day inspection in April 2017, raises questions about Fresenius' failure to adequately address a sterility failure. FDA sa...
  • Feature ArticlesFeature Articles

    How to Conduct Data Integrity Investigation Interviews

    Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...
  • Regulatory NewsRegulatory News

    FDA Warns California Device Company for Failing to Disclose Serious Injury

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices. Following an inspection last June and July, FDA said Hand Biomechanics failed to submit a report no later than 30 calendar days after it became aware of information that reasonab...
  • Regulatory NewsRegulatory News

    OPDP Issues Third Warning of 2017

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) this month issued its third warning or untitled letter of the year to Kentucky-based Magna Pharmaceuticals because its webpage and panels from a conference exhibit made false or misleading claims about the risks associated with and efficacy of its insomnia treatment Zolpimist (zolpidem tartrate). FDA said both Zolpimist’s webpage , supported by Amherst Pharmaceuticals, and exh...
  • Regulatory NewsRegulatory News

    FDA Warns, Blocks Imports From Chinese API Manufacturer

    Earlier this month, the US Food and Drug Administration (FDA) sent a warning letter to a Hubei, China-based active pharmaceutical ingredient (API) manufacturer related to several failures. The letter issued to Hubei Danjiangkou Danao Pharmaceutical Co. notes the company’s failure to demonstrate that its manufacturing process can reproducibly manufacture an API meeting predetermined quality attributes, a failure of its quality unit to approve changes that potentially...
  • Regulatory NewsRegulatory News

    Lupin Warned by FDA for Deficiencies at Two Facilities

    The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India. Lupin acknowledged receiving the warning letter in a Bombay Stock Exchange filing on 7 November, saying it had responded to nine observations stemming from FDA's inspections and that it will work to address the concerns raised in the warning letter. The warning letter says Lupi...