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Potential GMP Trouble Spots at India’s API Firms Include Equipment Handling, CAPA, Documentation, and Training, India Auditing Expert Finds

Potential GMP concerns among India’s expanding number of API suppliers include equipment handling, CAPA, documentation and training, Semler Research Center COO/Director Gurudatta Gayatri reported at the DIA Annual Meeting in June....

J&J Tallies Up the Impact of its Compliance and Recall Problems in Quarterly Investor Update

During a July 20 J&J investor’s conference call covering the company’s second quarter results, Investor Relations VP Louise Mehrotra provided an update on J&J/McNeil’s current compliance situation and the significant financial and operational impact of the firm’s compliance and recall problems (IPQ “In the News” May 6, 2010)....

FDA Concern with McNeil’s Complaint Handling Extends to Lancaster, PA Facility

McNeil’s complaint handling – a problem area cited in FDA’s January warning letter to parent company J&J regarding their Las Piedras, Puerto Rico plant and in an April inspection at the OTC drug manufacturer’s Fort Washington facility (IPQ “In the News,” May 6, 2010) – was also of concern to agency investigators in an inspection completed July 9 at McNeil’s plant in Lancaster, PA.

Congressional Investigation into J&J Recall Actions Widens to Include Contractors

Contract firms identified as helping Johnson & Johnson with what House Oversight committee chair Edolphus Towns (D-NY) has referred to as a “phantom recall” have now received letters from the committee from asking them to detail their roles in the action....

House Committee Chair Towns Asks J&J’s CEO for Detailed Information on McNeil Recall Actions

House Committee on Oversight and Government Reform Chair Edolphus Towns (D-NY) has sent a letter to Johnson & Johnson (J&J) CEO William Weldon requesting additional specific information on a market action taken regarding one of its Motrin products last year. Information requested on what Towns terms a “phantom recall” includes the names of J&J employees who were involved in making the decision to pursue this action, names of the contractors involved, and all records related to the action....

House Committee Hears from J&J and FDA on McNeil’s Recall and Compliance Problems

The House Committee on Oversight and Government Reform brought Johnson & Johnson (J&J) and FDA to the table on May 27 to take a hard look at J&J’s recent recall and GMP compliance problems. In focus at the Congressional hearing were J&J’s actions – including what was referred to by the committee as a “phantom recall” – FDA inspection findings, and possible further GMP and criminal investigations....

Teva Discontinues Propofol in the Wake of FDA GMP Concerns and Lawsuit Verdict

In the wake of GMP concerns resulting in an FDA warning letter and recall, and a clinical practice-related lawsuit verdict involving heavy punitive damages, Teva announced on May 28 that it will discontinue manufacturing its generic injectable emulsion version of the sedative propofol....

McNeil Voluntary Plant Shutdown, Product Recalls Follow FDA Inspection

On April 30, McNeil Consumer Healthcare, the OTC division of J & J, announced a recall of about 1,500 lots of liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl, and voluntarily shut down the plant where they were manufactured at the end of a two-week FDA inspection at their Fort Washington, PA facility....

Propofol Shortage Follows Teva and Hospira Warning Letters and Recalls

European manufacturer Fresnius is stepping in to help fill the US shortage in the injectible anaesthetic propofol caused by GMP problems at Teva and Hospira, resulting in warning letters and recalls. FDA's lengthy warning letter to TEVA in December, posted in April, focused on the manufacture of their generic version of propofol, and primarily related to microbial contamination and testing, including endotoxin in distributed product....

IPQ Special Report — May/June 2009

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not […]
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