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    FDA Hits Valeant’s Bausch & Lomb With Form 483

    The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile. The eight-day inspection last February uncovered four observations detailing : Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up Procedures designed to prevent microbiological...
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    FDA Official Dispels ‘100 Hours’ Myth on Time it Takes to Fill Out Compassionate Use Form

    The simplification of the US Food and Drug Administration’s (FDA) compassionate use process (announced last February and expected to be finalized very soon) may not actually be all that much of a simplification in terms of the amount of time it takes a physician to fill out the form, an FDA official told Focus on Tuesday. Richard Klein, director of the Patient Liaison Program in FDA’s Office of Health and Constituent Affairs, explained to Focus , following Monday’s ...
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    Form 483 Details Deficiencies at Catalent Facility Linked to Recent CRL

    • 19 April 2016
    The US Food and Drug Administration (FDA) last week released an inspection report citing major deficiencies at pharmaceutical contract manufacturer Catalent's Saint Petersburg, FL facility. The 14 deficiencies came to light in March after Opko Health announced it received a complete response letter from FDA for its prohormone drug Rayaldee (calcifediol) because of the "observations and deficiencies" at Catalent's manufacturing site. According to Catalent, the facility...
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    US FDA Inspections in China: An Analysis of Form 483s from 2015

    As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India. A Focus review (thanks to use of the Freedom of Information Act (FOIA)) of eight FDA Form 483s for Chinese manufacturers i...
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    FDA Warns Cancer Center Over Unsanitary Conditions

    The US Food and Drug Administration (FDA) has warned the Connecticut-based Johnson Memorial Cancer Center over unsanitary conditions in areas where the center prepares sterile drugs. The warning comes more than a year after FDA inspectors visited Johnson Memorial's Enfield, Connecticut site from 16 July 2014 and 5 August 2014. During their inspection, FDA found "serious deficiencies" in the center's practices for producing compounded sterile drugs. The letter lists six ...
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    FDA Form 483s From India: A Deep Dive Into the Problems

    Untitled Document A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers over the past two years reveals a slew of detailed quality concerns from the agency. And although the products described in the 483s have been redacted, and a majority of the FDA observations are for relatively commonplace documentatio...
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    FDA Details Theranos Deficiencies in Two Form 483s

    The heavily-redacted Form 483s released by the US Food and Drug Administration (FDA) on Tuesday for the blood testing company Theranos include 14 observations, with several on device design, classification and on how the company deals with complaints. Most recently, the highly-valuated Theranos has come under fire following a Wall Street Journal investigation that raised a number of questions about the accuracy of the company's proprietary blood testing technology and ...
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    NIH Suspends Drug Production Unit After FDA Inspection Finds Major Problems

    Pharmaceutical companies frequently find themselves sanctioned by the US Food and Drug Administration (FDA) for failing to adhere to federal good manufacturing practice (GMP) requirements. But it's an exceptionally rare occurrence to see FDA cracking down on a fellow federal government agency, as it is this week. On 4 June 2015, the National Institutes of Health (NIH) issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) ...
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    US FDA Proposes Changes to MedWatch Program for Healthcare Products

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products. The Food and Drug Administration is seeking comment through July 1, 2015 on  changes  to three reporting components of its MedW...
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    FDA Making Changes to its Drug Advertising Review Process

    A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional materials for review by regulators. Background At present, all pharmaceutical advertisements aired or distributed by companies must be submitted to FDA's Office of Prescription Drug Promotion (OPDP)—formerly known as the Division of Drug Marketing, Advertising and Communication...
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    FDA Chides Contact Lens Manufacturer for Ignoring Earlier Warning

    A recent Warning Letter sent by the US Food and Drug Administration (FDA) to a medical device manufacturer contains good advice to any firm facing an enforcement action from federal regulators: Ignoring the issue will not make it go away. Background FDA's letter was sent to California-based contact lens manufacturer Visionary Contact Lens. The company, which makes rigid gas-permeable contact lenses, was inspected by FDA officials in January and February 2015. During F...
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    The Tip of the Iceberg: What Lurks Beneath the 483

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com . At the end of a grueling week spent sitting in a conference room with an in...