FDA findings at Ben Venue’s Bedford, Ohio injectable manufacturing facility in 2011 that GMP problems cited in a 2007 warning letter had still not been corrected resulted in a consent decree, approved by the US District Court for Northern Ohio on January 31.
The 47-page decree traces the history of the plant’s noncompliance and defines the company’s remediation pathway going forward.
The Ben Venue consent decree is the fifth involving GMP compliance at drug and biotech companies since the beginning of 2010. The other consent decrees were with Ranbaxy, McNeil, Deltex and Genzyme (see box below).
In the “complaint for permanent injunction” accompanying the Ben Venue consent decree, the court notes that the deviations observed by FDA during a late-2011 inspection of the company “were similar to deviations observed by FDA investigators during their many previous inspections of the BVL facility.”
The injunction points out that the recurrent problem areas were detailed in the previous inspection in May 2011, during which agency investigators documented forty-eight separate CGMP deviations. The recurrent problem areas included: ● an inadequate quality control unit ● inadequate and untimely investigations ● inadequately designed aseptic processing areas ● poor employee aseptic practices ● failure to prevent microbial contamination of drug products purporting to be sterile, and ● failure to determine the root cause for microbial contaminants and particulates. [Editor’s Note: For an analysis of Ben Venue’s May and Nov./Dec. 2011 inspections, see IPQ “The News in Depth,” November 29, 2011.]
In a press release issued after signing off on the consent decree, Ben Venue reported that it has invested more than $300 million to upgrade its facilities, “making necessary improvements and changes to processes to address the manufacturing-related issues that resulted in the company’s decision to voluntarily halt manufacturing in November 2011.”
According to the release, the company “has demonstrated progress in improving manufacturing processes, and announced in October 2012 that limited production had resumed. Since that time, production has resumed on additional manufacturing lines.”
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See related IPQ stories:
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Growing Cooperation Between FDA and EMA Highlighted in Ben Venue Inspections
Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections
Ranbaxy Consent Decree Fires FDA Warning Shot for Ex-US Pharma on Data Integrity
McNeil Consent Decree Reflects Previous Big Pharma Injunctions Minus Disgorgement
Deltex Injunction Follows History of Lab GMP and Unapproved Drug Compliance Problems
Genzyme Consent Decree Results in $175 Million Fine, Drug Shortages Will Continue
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