Drug GMP Report

The FDA’s consent decree for Ranbaxy requires third-party audits of four facilities and it can be expanded to other plants if future inspections reveal compliance or data integrity issues, making it “unprecedented in scope,” the Department of Justice (DOJ) says.

Genzyme can begin manufacturing Fabry disease drug Fabrazyme at its Framingham, Mass., plant after winning FDA approval for the facility.

The international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its charter to include language promoting global harmonization of good distribution practices (GDP) and confidentiality in data sharing.

A new Form 483 for Novartis Consumer Health’s Lincoln, Neb., facility cites a litany of manufacturing failures and instances of tablets gone wild, with products found in odd areas of the plant’s packaging line — GMP deficiencies that prompted a nationwide recall last month.

Pfizer is voluntarily recalling 14 lots of its oral contraceptive Lo/Ovral-28 and 14 lots of the norgestrel and ethinyl estradiol generic product as some blister packs may be missing tablets or displaying tablets out of sequence.

LNK International, a contract manufacturer of more than 100 OTC drugs, failed to adequately investigate several customer complaints of foreign tablets and/or short counts, a Form 483 states.

An investigation of Baxter’s Neuchatel, Switzerland, facility found inadequate documentation of stability data and lack of corrective and preventive action (CAPA) procedures, a Form 483 states.

Canadian drugmaker Cangene’s Baltimore, Md., plant was handed a form 483 after a recent inspection found a lack of procedures for equipment cleaning and maintenance and inadequate adherence to procedures to prevent microbiological contamination of products.

The U.S. government confiscated more than $16.8 million in counterfeit pharmaceuticals in 2011, nearly three times the value of the fake drugs seized a year earlier.

Remediation efforts to right manufacturing woes at Hospira’s Rocky Mount, N.C., facility and other plants are expected to cost between $300 and $375 million through 2013, but enough progress has been made at Rocky Mount to presume a return to production within weeks, Hospira CEO Michael Ball says.

Following discussions with the FDA, Ben Venue Laboratories is announcing that it made a voluntary August 2011 recall of three injectable-drug products made at its ailing Bedford, Ohio, plant.

Lpath is suspending dosing in two trials of its eye drug iSONEP after learning of compliance issues at its fill/finish contractor Formatech.

Gordon Richman, vice president, Strategic Compliance Consulting, and general counsel of EduQuest, answers questions about how drugmakers should evaluate and respond to FDA Form 483s.

Johnson & Johnson (J&J) must again reorganize its consumer products group less than a year after shaking it up in the wake of a monster consent decree.

The FDA formally closed out a Jan. 14, 2010, warning letter citing Sunrise Pharmaceuticals for manufacturing some of its products with excess active pharmaceutical ingredient (API) without justification in the batch records.

FDA Commissioner Margaret Hamburg is adopting eight proposals for improving public access to compliance and enforcement data, including ways to speed data disclosure.

Teva subsidiary Cephalon is voluntarily recalling its cancer drug Treanda after glass particles were found in a single vial in one lot, the FDA says.