Audits and Inspections

Industry is taking a step forward by addressing supply-chain integrity through the formation of Rx-360. PhamTech's podcast explores the subject.

The UK's Medicines and Healthcare Regulatory Agency (MHRA) has published the outcome of a consultation on measures to strengthen the country's drug supply chain.

Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) introduced legislation last Thursday that would give the US Food and Drug Administration more resources to inspect domestic and foreign plants that manufacture drugs and medical devices.

In late March, the US Food and Drug Administration sent warning letters to nine companies to stop manufacturing 14 unapproved narcotic drugs. Less than two weeks later, on Apr. 9, the agency amended those letters when it realized that one particular unapproved opioid (a high concentrate of morphine sulfate oral solution) is desperately needed by patients.

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

The US Food and Drug Administration announced that it had filed a Consent Decree on Dec. 23, 2008 and was awaiting the court?s entry of a permanent injunction that bars Actavis (Hafnarfjordur, Iceland), its officers Sigurdur Oli Olafsson and Douglas Boothe, and its subsidiary Actavis Totowa (Totowa, NJ) from manufacturing and distributing drugs at the Actavis Totowa facilities.

US marshals seized 11 lots of heparin from Celsus Laboratories (Cincinnati, OH) at the request of the US Food and Drug Administration.

The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories.

To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.

Merck and Company?s West Point, Pennsylvania facility received a Warning Letter from the US Food and Drug Administration.

The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.

Noven Pharmaceuticals received a warning letter from the US Food and Drug Administration stemming from an on-site inspection of the company?s manufacturing facility in Miami, Florida, concluded July 2007.

The US Food and Drug Administration has issued Ben Venue Laboratories a Warning Letter resulting from CGMP deviations found during an inspection of the company?s ?Propofol? injectable emulsion manufacturing facility earlier this year.

The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.

Offshore contracting is nothing new for the pharmaceutical industry. Neither is importing active ingredients, or prescription drugs, for that matter. But the authorities are having trouble keeping up with these growing international trends.

Rockville, MD (May 25)-The US Food and Drug Administration issued a Form FDA 483, Inspectional Observations, to the Liverpool, United Kingdom, facility of MedImmune, Inc., citing deviations from current good manufacturing practices.

Rockville, MD (Mar. 1)-The number of US Food and Drug Administration inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs.

Rockville, MD (Mar. 1)-Sending Warning Letters to 8 manufacturers and 12 distributors, The US Food and Drug Administration ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate.

Rockville, MD (Jan. 5)-The US Food and Drug Administration issued a Warning Letter to Bell-More Laboratories following the agency?s August 2006 inspection of the company?s Hampstead pharmaceutical facility.

Rockville, MD (Feb. 1)-The US Food and Drug Administration issued a revised warning letter to Actavis Totowa, LLC, citing ?significant deviations from the current Good Manufacturing Practice regulations.?

Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration in 2006.

Dallas, TX (Nov. 7)-The US Food and Drug Administration has posted a Warning Letter from its Dallas District office to Matheson Tri-Gas, Inc.

The US Food and Drug Administration's New Jersey District Office issued a Warning Letter to Concord Laboratories (Fairfield, NJ), citing the company for manufacturing three generic products without an ANDA, and for ten deviations from current good manufacturing practices.

On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe, Inc. (Corona, CA) by FDA's San Juan (PR) district office.

Vaccine maker Sanofi Pasteur, Inc. received a US Food and Drug Administration Warning Letter, dated June 30, citing "significant deviations" from current good manufacturing practices in the production of monovalent concentrates used in the company?s ?Fluzone? influenza vaccine.

On June 15, 2006, the US Food and Drug Evaluation?s Center for Drug Evaluation and Research (Rockville, MD) issued a 7-page warning letter to Ranbaxy Laboratories (Himachal Pradesh, India) for violations to US current good manufacturing practices.

This week, the US Food and Drug Administration (Rockville, MD) posted a Warning Letter issued May 31 by its New Jersey District Office (Parsippany, NJ) to Neil Laboratories (East Windsor, NJ) for CGMP deviations.

On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).

On Feb. 21, the US Food and Drug Administration issued a warning letter to Wockhardt (Mumbai, India), a drug manufacturer. FDA cited the company for violations of CGMPs in the manufacture of drug products and active pharmaceutical ingredients.