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    FDA Warns Korean Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 28 November to Korea-based Barox Co., Ltd. for significant violations of current good manufacturing practice (CGMP) regulations. FDA said the firm relabels over-the-counter drug products manufactured by a contract manufacturer and then distributes the drugs to the US. “You have no written documents describing roles and responsibilities of a Quality Control Unit (QCU). All of your empl...
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    FDA Warns Korean Drugmaker Over Poor Aseptic Practices, Patchy Lab Records

    South Korea-based Hanlim Pharm Co. drew a US Food and Drug Administration (FDA) warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP). The FDA inspection of the company’s drug manufacturing facility in Gyeonggi-do earlier this year concluded that similar GMP violations had been observed during FDA visits to the site in 2014 and 2016. The repeat observations underscore a need for ...
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    CBER Sends Untitled Letter to Marketer of Unapproved Allergy Spray

    The US Food and Drug Administration’s (FDA) Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) sent an untitled letter to the owner of two websites purporting to sell allergy treatments that have not been approved.   The company Telogenes, LLC boasts that its product, known as Ollereg, “contains FDA-approved allergens used off label for oral immunotherapy,” among other claims, but FDA raised concerns.   “Based on t...
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    FDA Warns BD for GMP Violations at Lock Flush Syringe Facility

    The US Food and Drug Administration (FDA) has warned medical device maker Becton Dickinson (BD) for good manufacturing practice (GMP) violations at the company’s Franklin, Wisconsin facility.   The warning letter comes after two-and-a-half-month inspection this summer during which FDA found the company’s pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe products to be adulterated.   The warning is BD’s second in 2018 after...
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    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...
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    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...
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    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...
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    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 ...
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    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...
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    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...
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    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...