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...

Late last year, US officials announced what they said was a breakthrough for the US Food and Drug Administration's (FDA) efforts to ramp up its inspection presence in China-a region with increasing pharmaceutical exports to the US. Background Under the terms of the December 2013 agreement between White House and Chinese officials, China was set to allow a "substantial increase in the number of US food and drug inspectors stationed in China," according to a White House...

The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration's (FDA) track record of inspecting generic pharmaceutical manufacturers in the coming year, the group said. Background OIG is DHHS' investigative body, and serves to audit agency programs and make recommendations as to how they can improve. Often times their reports are also used by members of Congress to push for changes. O...

The US Food and Drug Administration (FDA) has for years struggled with an influx of generic drug applications to the Center for Drug Evaluation and Research (CDER), resulting in a massive backlog that is only just starting to clear thanks to an influx in new user fee funding. But more than just the influx of abbreviated new drug applications (ANDAs), FDA's review resources have been stretched by the fact that many generic drug manufacturers are located outside the US, m...

If you follow the US Food and Drug Administration's (FDA) Warning Letters with any regularity, you know that the agency has been keeping a tight eye on Indian pharmaceutical manufacturers. But under the terms of a recent agreement, Chinese companies might soon find themselves in similar circumstances. Background FDA has long been hamstrung in its ability to inspect foreign manufacturers of pharmaceutical products, and in particular generic pharmaceuticals and active pha...

The US Food and Drug Administration (FDA) is out with a new draft guidance for industry establishing a framework by which a pharmaceutical manufacturer may delay, deny, limit or refuse an inspection of a facility by FDA. Background The draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection , released 12 July 2013, comes almost exactly one year after the passage of the Food and Drug Administration Safety and Innov...

US regulators announced this week their intent to continue a program they say allows companies to invite pharmaceutical regulatory officials into their facilities to go on site tours to learn more about the pharmaceutical industry and the way it produces its products. Background: Site Tours Program The plan, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999,...

A South Korean medical device company is at the receiving end of a particularly blunt warning letter in which US regulators accuse the company of fixing almost none of the problems they found during a 2010 inspection. The 26 November 2012 letter to Seoul-based Sometech Incorporated, manufacturer of medical imaging equipment and high-frequency surgical instruments, references an April 2012 inspection by the US Food and Drug Administration (FDA). During that inspectio...

Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...

Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis. The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 release...