By FDA inspection report standards, the length of the document alone suggests the magnitude of the quality and manufacturing compliance issues at Ben Venue, an arm of Boehringer Ingelheim. The 33 pages comprise a Form 483 inspection report issued to the company after a May 2011 inspection. Within those pages are 48 counts of GMP violations.
The report, available as the result of a Freedom of Information Act request by Dow Jones, paints a picture of Ben Venue's Bedford, OH, plant and the processes running within it. In addition to finding stainless steel particles in two products, inspectors note Ben Venue failed to identify the cause. "Neither a definitive root cause nor a corrective/preventative action has been identified or implemented," the report says.
Inspectors noted "a lack of adequate oversight" by the QC unit to approve or reject the products manufactured and the processes and procedures used in manufacturing.
"Ben Venue takes the FDA investigators' observations seriously," company spokesman Jason Kurtz says in an email. "Since the inspection, we have made a number of changes in manufacturing operations to resolve the issues cited in the inspection report. We continue to work closely with the FDA."
Some of the violations cited in the Form 483 report relate to the design of the facility itself: In a Class 100 aseptic filling room, plastic airflow curtains didn't protect products from contamination. In fact, the report says, "personnel entry and exit via the plastic barrier curtains promote the ingress of objectionable microorganisms and non-viable particles."
In addition, manufacturing records were found to contain inaccurate counts of vials filled and no reconciliation to account for all the filled vials. The document also contains reports of microbial contamination and rain water leakage from the ceiling into the sterile storage area.
Among Ben Venue's clients was Johnson & Johnson ($JNJ) for its cancer drug Doxil, which is currently in short supply, according to The Wall Street Journal.
- see the WSJ story
- here's the Form 483 inspection report