Drugs

Troubled Lupin Hires Former FDA NJ District Director

India-based Lupin Pharmaceuticals has hired recently retired FDA New Jersey District director Diana Amador-Toro as the company’s senior vice president of global compliance. Based in Somerset, NJ, Amador-Toro presumably will be charged with helping to correct ongoing violations at Lupin’s New Jersey manufacturing facility.

The plant was hit with a Warning Letter a year ago over GMP violations that the agency said were similar to violations at other Lupin facilities. Specific violations were:

failing to establish and follow adequate written procedures for cleaning and maintenance of equipment;
failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to establish and follow adequate written responsibilities and procedures applicable to the quality control unit.

A March inspection at the plant this year resulted in a 13-item FDA Form-483 that cited the firm’s quality system, which it said was a repeat finding, for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. It also found the responsibilities and procedures for the quality control unit are not in writing and fully followed. And it said procedures describing the handling of all written and oral complaints regarding a drug product are not written and followed. Other repeat findings include:

Employees lack the training required to perform their assigned functions.
Written procedures are not established and followed for the cleaning and maintenance of equipment
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components conform to appropriate standards.

A CNBC report says Amador-Toro’s global compliance functions will focus on training, internal audits and investigations.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome