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  • Regulatory NewsRegulatory News

    FDA warns Battelle over EUA conditions for N95 decontamination system

    The US Food and Drug Administration (FDA) on Wednesday warned Battelle Memorial Institute for failing to comply with some of the conditions of its emergency use authorization (EUA) for its decontamination system for N95 respirators.   The warning letter is the first FDA has issued concerning a product being used under an EUA during the COVID-19 pandemic.   In March, Battelle became the first organization to receive an EUA for a decontamination system for N95 respir...
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    FDA warns Sprout for misleading Addyi come-on

    Sprout Pharmaceuticals’ promotion of Addyi both mischaracterizes the drug’s indication and downplays potential serious adverse events associated with its use, according to a warning letter from the US Food and Drug Administration (FDA).   Sprout Pharmaceuticals markets the non-hormonal drug Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. To meet HSDD criteria, low desire must cause marked distress or i...
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    FDA warns Mylan, Acella Pharmaceuticals over GMP violations

    The US Food and Drug Administration (FDA) last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations.   Mylan Laboratories   FDA’s warning letter to Mylan comes after the agency inspected the company’s facility in the Sangareddy District of Telangana, India over the course of a week last February.   The warning letter, which cites the company for issues related to its cleaning procedures and handling of r...
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    OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot

    Xeris Pharmaceuticals last week received the first untitled letter sent by the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) in 2020 over claims made in a television ad for its Gvoke (glucagon) pre-filled syringe.   The letter is only the second enforcement letter sent by OPDP this year after the office warned Outlook Pharmaceuticals for omitting risk information in a sponsored link on Google, marking a particularly light year for...
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    FDA warns California-based CDMO, Mexican drugmaker

    The US Food and Drug Administration (FDA) earlier this month warned two companies, contract development and manufacturing organization (CDMO) Stason Pharmaceuticals and Mexican drugmaker Signa SA de CV.   Stason Pharmaceuticals, Inc.   In its warning letter to Irvine, CA-based CDMO Stason Pharmaceuticals, FDA cites the company for product testing and data integrity issues uncovered during a three-week inspection last October.   According to FDA, the company w...
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    FDA sends first warning letters for fraudulent marketing of antibody tests

    The US Food and Drug Administration this week issued its first set of warning letters for marketing adulterated or misbranded COVID-19 antibody tests.   The letters, sent to Medakit Ltd. of Hong Kong,  Antibodiescheck.com of United Arab Emirates, and Sonrisa Family Dental dba www.mycovidtest19.com of Chicago, cited a range of violations. These included offering test kits for sale in the US directly to consumers for at-home use without marketing approval, cleara...
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    FDA warns Takeda over aseptic processing, inadequate investigations

    The US Food and Drug Administration (FDA) last week warned Japanese drugmaker Takeda Pharmaceutical over good manufacturing practice (GMP) violations observed during an inspection of its Hikari, Yamaguchi facility last November.   Specifically, the warning letter cites the firm for three violations relating to its procedures for aseptic manufacturing and investigations into unexplained discrepancies and equipment malfunctions.   “Our inspection found that your Qual...
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    FDA Warns Massachusetts PET Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Woburn, Massachusetts-based PETNET Solutions Inc. after an inspection last spring uncovered unclean conditions and failures in environmental monitoring for the positron emission tomography (PET) drug manufacturing site’s aseptic operations. The letter notes that the FDA inspector “observed a state of disrepair and lack of cleanliness” at the site, while “sporeforming fungi were repeat...
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    FDA Warns California Drug Distributor for Listing Deficiencies

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Orange, CA-based distributor NuCare Pharmaceuticals after the company failed to correct certain drug listings. FDA said that since it first contacted NuCare in August 2017, some of the incorrect listings outlined in deficiency letters have been addressed and corrected, but many remain unresolved.  The agency points to multiple incorrect carton labels or missing information on the s...
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    FDA Warns Chinese Drug Testing Facility for Refusing Inspection

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in August to China-based drug testing facility Shanghai Institute of Pharmaceutical Industry for refusing an inspection. FDA had planned a surveillance and pre-approval inspection of the facility from 29 November to 4 December 2018, but the company told FDA’s China office in a written response that it was refusing the inspection. "Under section 501(j) of the Federal Food, Drug, and Co...
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    FDA and DEA Jointly Warn Illegal Online Opioid Networks

    In a first for the US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), the agencies came together to warn four online networks operating 10 websites that illegally market unapproved and misbranded versions of opioids. FDA notes that the illegal online pharmacies may put people at risk because there is no guarantee that the medicines are safe and because several of these websites sell opioids online without a prescription. In the warning l...
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    CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications

    The videos at 21 st Century Scientific’s website wheelchairs.com show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told the Idaho-based company in a warning letter posted Tuesday that these modifications to their wheelchairs were never approved by the agency. “Use on these terrains and functions that enable the device to lift the user, tilt the...