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...

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 ...

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 ...

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) ...

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...

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...

The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of biologics manufacturing facilities, indicating the most common issues faced by biologics companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 146 Form 483s—forms indicating areas of noncompliance at a facility—to biologics companies in fiscal year 2014. T...

The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of pharmaceutical facilities, indicating the most common issues faced by pharmaceutical companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 645 Form 483s—forms indicating areas of noncompliance at a facility—to pharmaceutical companies in fiscal year 2014. ...

The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 972 Form 483s—forms indicating areas of noncompliance at a facility—to medical device companies in fiscal year 2014. ...

The US Food and Drug Administration (FDA) has released the text of a Form 483 sent to biopharmaceutical manufacturer Biogen Idec, outlining a series of alleged deficiencies affecting the manufacture of two of the company's multiple sclerosis drugs, Tysabri (natalizumab) and Avonex (Interferon Beta 1a). FDA issues Form 483s if, during the course of an inspection of a manufacturing facility, its inspectors find deficiencies in need of addressing. If the issues are serious ...

Guidance documents, as the US Food and Drug Administration (FDA) often reminds industry, are not legally binding entities. Rather, they represent insight into regulators' current best thinking on a particular subject, giving companies the opportunity to make compliant their operations and avoid any regulatory headaches. But just because they're not legally enforceable on their own doesn't mean that FDA isn't interested in taking action in accordance with the regulations ...

Several weeks ago, US regulators announced that supposedly sterile products manufactured by a Tennessee compounding pharmacy were contaminated with fungus and bacteria, leading to a recall of the company's products and raising troubling parallels between the case and another one that killed dozens and left hundreds seriously injured. Now the US Food and Drug Administration (FDA) has released the details of its inspection of that compounders' facility, revealing disturbing...