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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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    FDA Warns Drug Manufacturers as FTC Warns CBD Advertisers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to South Korea-based drug manufacturer Enprani Co. and China-based drug manufacturer Hangzhou Badi Daily Use Chemical Company. Meanwhile, the Federal Trade Commission (FTC) on Tuesday said it sent warning letters to three unnamed companies for illegal advertising of products containing cannabidiol (CBD). The letter for Enprani, which follows a five-day inspection last March, shows how...
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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 Warns Five Homeopathic Product Manufacturers for GMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to five homeopathic product manufacturers because of significant good manufacturing practice (GMP) violations. For instance, four of the companies jointly manufacture and package Puriton Eye Relief Drops, which are labeled as homeopathic. But FDA said it tested multiple samples and found the eye drops were non-sterile, which could lead to an eye infection, and had a high pH level, which c...
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    Texas Firm Draws FDA Warning Over Adulterated Device

    In a new US Food and Drug Administration (FDA) warning letter, Plano, TX-based Surgisil was urged to come into compliance with the marketing of its Perma Facial Implant over an unapproved intended use. FDA conducted an inspection of Surgisil’s operations, including its website , last September and determined the firm had been marketing the Perma Facial Implant for augmentation of the lips. The device obtained 510(k) clearance for “cosmetic augmentation and correction...
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    FDA Flags Incidents of Excess Radiation Exposure to Patients

    The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans. The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high lev...
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    FDA to Step Up Stem Cell Enforcement, Look Into Pathway for Low-Risk Treatments

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation Research (CBER) Director Peter Marks on Wednesday warned that the agency will step up its enforcement efforts against companies illegally marketing stem cell therapies.   Gottlieb and Marks also said the agency will look into new ways to “delineate an efficient development path” for low-risk stem cell therapies being developed by firms that have filed investigational n...