The Medicines and Health Care products Regulatory Agency (MHRA) on Wednesday cited US-based contract manufacturing organization Pharmaceutics International, Inc. (Pii) for critical deficiencies at two of its Maryland facilities. In the reports, outlined in two separate statements of non-compliance published to the European Medicine Agency's (EMA) EurdraGMP database, the inspectors say they identified a "failure of organizational and technical measures to minimize the ris...

The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns. The review follows a joint good clinical practice (GCP) inspection of this site by German and Dutch regulators in March 2015, which raised issues with study data used to support the marketing authorization applications of some medicines in the EU. Following consideration of the inspectio...

A South Korean insulin syringe and pen needle manufacturer on Wednesday became the fifth foreign company to currently have its products banned from entry into the US after denying an inspection by the US Food and Drug Administration (FDA). Seoul, Korea-based MedExel Medical Manufacturing Co., which manufactures insulin syringes and insulin pen needles in Korea, joined Taiwan’s Morris Engineering Works, India’s Sewa Medicals, and China’s Intop Tech and Shanghai Realov E...

In 2012, the US Food and Drug Administration (FDA) was granted new authority to go after pharmaceutical companies that were, in its opinion, preventing regulators from fully inspecting drug and device manufacturing facilities. If a company way "delaying, denying, limiting or refusing" an FDA inspection, the law stated, FDA could deem a drug to be adulterated and prevent it from being sold. But as a new legal analysis finds, FDA has done little to define the difference be...

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 Last month we explored the rates of US Food and Drug Administration (FDA) inspec...

China is a mysterious and interesting country for the regulatory professional. It is of interest because of its enormous market potential (nearly a fifth of the world’s population lives in the People’s Republic of China) and the fact that China is one of the most important manufacturers of active pharmaceutical ingredients (APIs) for the EU and US. China exported 1.2 million tons of APIs to the EU and 0.6 million tons to the US in 2013. China is somewhat mysterious becau...

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 It’s generally nerve-wracking when the US Food and Drug Administration (FDA) sho...

The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections. Background In July 2013, FDA released a draft guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection seeking to clarify its newfound authority under the Food and Drug Administration Safety and Innovation Act (FD...

In one of the most unusual Warning Letters sent by the US Food and Drug Administration (FDA) this year, a dietary supplement manufacturer has been chided by regulators for allegedly failing to allow an inspector to fully inspect the facility, allegedly because the products manufactured there contained an active ingredient also contained in Pfizer's Viagra. Background As recounted in FDA's 26 September 2014 Warning Letter, FDA inspectors arrived at Pennsylvania-based Nov...

The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators. The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection , and the other for failing to operate according to good manufacturing practi...

A Canadian subsidiary of pharmaceutical company GlaxoSmithKline (GSK) has been accused by the US Food and Drug Administration (FDA) of deviating from good manufacturing practice (GMP) regulations while manufacturing the flu vaccine FluLaval . The allegations, contained in a Warning Letter released by FDA on 24 June 2014, stem from a 31 March-9 April 2014 inspection of ID Biomedical Corporation's—a GSK subsidiary since 2005—Quebec facility. The bulk of the allegati...

Unless you've been paying close attention, you'd be forgiven for missing one of the biggest stories at the US Food and Drug Administration (FDA) this year. While the agency has been sending letter after letter to manufacturers in India, until this week the agency hadn't sent a single Warning Letter to a company in China—a curious trend following the 38 sent to Chinese companies since 2008 and the six it sent to them last year alone. Background The lapse in Warnin...