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  • Regulatory NewsRegulatory News

    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 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...
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    CDER Warns Chinese, Indian Manufacturers

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released two warning letters sent recently to India-based active pharmaceutical ingredient (API) manufacturer CTX Lifesciences Private Ltd and China-based drug manufacturer Ningbo Pulisi Daily Chemical Products Co. Following a six-day inspection at CTX Lifesciences, FDA found that the firm did not ensure that the water used for parenteral grade APIs was suitable for its...
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    FDA's OPDP Warns Metuchen Pharmaceuticals Over Misleading DTC Ads

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Metuchen Pharmaceuticals earlier this month for several false and misleading advertisements for its erectile dysfunction drug. In several print and online ads, including one in the American College of Cardiology’s magazine, the drug, known as Stendra (avanafil), is portrayed as being approved for a new use for which it lacks approval, and several misleading ...
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    FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research earlier this month sent a warning letter to China-based sunscreen and OTC drug manufacturer NingBo Huize Commodity Co. after the company’s general manager and quality manager admitted that multiple documents provided to FDA were falsified “for the purpose of this inspection.” FDA placed the firm on import alert in June and said that the firm agreed to recall all drug products distributed...
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    FDA Warns Akorn for Repeat Violations

    Following a more than one-month inspection last summer, the US Food and Drug Administration (FDA) on Tuesday released a warning letter for Akorn’s Somerset, New Jersey manufacturing facility due to cGMP violations. The warning letter, issued 13 June and discussed by Akorn on 25 June, echoes some of the observations made by FDA in a Form 483 for the site last November. FDA specifically raises concerns with the site’s quality system, which “does not adequately ensu...
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    FDA Questions Arizona Stem Cell Company

    As part of efforts to crack down on companies selling unapproved stem cell products to treat a variety of diseases and conditions, the US Food and Drug Administration (FDA) on Thursday sent an untitled letter to Arizona-based R3 Stem Cell and its more than 50 affiliate centers or clinics. FDA raises concerns with R3 because its website makes unsubstantiated claims about the stem cell products, which FDA says appear to be human cell, tissue, or cellular or tissue-based p...