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  • Regulatory NewsRegulatory News

    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...
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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...
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    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements. The warning letters were made public by FDA late Tuesday and sent to Sientra and Mentor Worldwide on Monday for being in violation of two of the seven requirements established as part of their devices’ conditional approvals. They underscore an emerging FDA enforcement trend around PA...
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    FDA Warns Integra’s TEI Biosciences Over Contamination Issues

    A TEI Biosciences medical device facility drew an US Food and Drug Administration (FDA) warning letter earlier this month over failures to prevent bacterial contamination of certain manufacturing equipment and products. The warning letter, made public on Tuesday, cites four good manufacturing practice (GMP) violations for the manufacturer of collagen-based medical devices. The first three GMP violations cover a lack of procedures to control environmental conditions as w...
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    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...