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Theqmnweeklybulletin

July 27, 2012

Vol. 4 No. 30

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Supply Chain Risk Management Standard to Address Pharma Compliance Concerns

A planned, first-of-its-kind U.S. standard on supply chain risk management will include input from a handful of drugmakers to highlight the impact that compliance lapses have on supply chain security, says the chair of a newly formed industrywide panel developing the standard. Read More

UK Devicemaker Warned by FDA on Documentation, Production

Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant. Read More

MDUFA III Signed Into Law; Clock Ticking on Enacting Changes

President Barack Obama signed the FDA Safety and Innovation Act, S. 3187, into law July 9, reauthorizing the Medical Device User Fee Act (MDUFA) and Prescription Drug User Fee Act, and creating new user fee programs for generic drugs and biosimilars. Read More

Lawyer: Synthes Case Highlights Considerations in RCO Pleas

Last year’s court ruling that sent four former Synthes executives to prison for clinical trial deaths represents an expansion of case law and a warning to other devicemakers, a legal expert says. Read More

Manufacturing Concerns in CRL for Luitpold

The FDA has handed Luitpold Pharmaceuticals a Complete Response Letter (CRL) on its NDA for Injectafer after a recent inspection raised concerns about the drugmaker's Shirley, N.Y. manufacturing facility. Read More

Siemens Gets Warning Letter: Complaint Handling Problems Cited

Siemens Healthcare Diagnostics has received its second FDA warning letter this summer, following an inspection of the company’s Newark, Del., plant. Read More

Lax Investigations Into Discrepancies Lands A&Z Pharmaceutical a Form 483

A&Z Pharmaceutical failed to adequately investigate unexplained discrepancies in drug products tied to compression-related troubles at the company’s Deer Park, N.Y., plant, a Form 483 states. Read More

Electro-Cap Handed 483 for Validation Procedure Lapses

The FDA’s Cincinnati District Office issued a Form 483 to a maker of electroencephalogram application caps and related supplies due to missing validation and control procedures at its Eaton, Ohio, plant. Read More