Audits and Inspections

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

A new audit guide aims to improve supply-chain security and supplier qualification practice.

Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

A US Food and Drug Administration inspection completed on Dec. 9, 2010 revealed persistent deficiencies at McNeil Consumer Healthcare's Fort Washington, Pennsylvania, facility.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

From fiscal year 2007 to 2009, the US Food and Drug Administration increased the number of foreign drug inspections it conducted, but the agency still conducted fewer foreign inspections than domestic inspections each year, according to a recent report by the US Government Accountability Office (GAO).

The European Generic medicines Association (EGA) has made a number of recommendations on how to ensure the quality of medicines in the globalized supply chain; in particular, the EGA spoke about API quality and quality supervision, and how these can be improved by transparent communication between authorities and industry.

The EDQM inspection program helps to ensure the quality of APIs on the European market.

The US Food and Drug Administration recently issued a Warning Letter to Bristol-Myers Squibb (BMS, New York) for violations of current good manufacturing practice at the company's Manati, Puerto Rico, manufacturing facility.

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

Novartis has been told off by the FDA in a letter about a social media Facebook widgit that appears on the company?s Tasigna website.

The Office of the Inspector General for the Department of Health and Human Services (HHS) issued a report, Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials, which evaluates the incidence of foreign clinical trials, the ability of the US Food and Drug Administration to oversee these trials, and recommendations to FDA on how to improve its oversight of foreign clinical trials.

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

FDA Issues Warning Letter To Pfizer; And More.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

FDA Issues Warning Letters to Six US Medical Spas; and More.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

FDA Issues Warning Letter To Paddock Laboratories; And More.

Margaret Hamburg, commissioner of the US Food and Drug Administration, unveiled a new program to improve the efficiency of import inspections.

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

FDA Issues Warning Letter To McNeil Healthcare; Charles River Laboratories Will Suspend Operations At Massachusetts Facility.

The US Food and Drug Administration has issued 22 Warning Letters to website operators as part of its International Internet Week of Action.

The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance.

The two agencies issued a joint Warning Letter to the owners of a website selling unapproved products intended to treat the swine flu virus.

The FDA has sent Bayer Schering Pharma (Germany) a Warning Letter, citing deviations from cGMP in the manufacture of nonsterile APIs.

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

Also, USP signed a Memorandum of Understanding with the Permanent Commission of the Pharmacopeia of the United Mexican States, more...

The US Food and Drug Administration announced a new program regarding the issuance of warning letters to the pharmaceutical industry.

US Food and Drug Administration Commissioner Margaret Hamburg outlined last week six initial steps designed to improve the effectiveness and timeliness of FDA's regulatory and enforcement system.