Under the terms of the decree, the Boehringer Ingelheim unit cannot make or sell certain drugs, but there are exceptions. Ben Venue can continue manufacturing and distributing more than 100 drugs deemed "essential for patient care," as well as continue drug-development activities. The drugmaker may also file abbreviated new drug applications and, possibly, win ANDA approvals, according to a company statement and court documents.
The Bedford, Ohio, facility has had a very troubled record. The FDA found 10 violations of good manufacturing practices during a late 2011 inspection and 48 violations in May 2011. In fact, the agency conducted 35 inspections since 1997
2007 and Ben Venue initiated some 40 recalls since February 2002, including nine considered to be Class I, which is the most serious type of recall because it can lead to potential harm, according to court documents (here is the government lawsuit and the consent decree).
Despite dozens of inspections, a warning letter and numerous conferences, Ben Venue repeatedly failed to comply with manufacturing regulations, the government lawsuit notes. The drugmaker, however, tried to avoid letting its failings become public. When we first reported the many difficulties in 2011, Ben Venue publicly blamed capacity constraints and did not acknowledge ongoing quality control problems.
But a so-called 483 inspection report found metallic particles or flakes in some medicines, which inspectors suggested came from scrapes on metal doors or window frames; rain water leaking through a ceiling; operators used gloves that were not sterile and shedding fibrous materials; bacterial contamination in some batches of medicines and mold in classified areas, including manufacturing areas (here is the report).
There was also an embarrassing bit of mystery contained in the report. An unknown liquid was found in a 10-gallon can in a storage area in one of its facilities, and an independent lab determined this was urine, yet a detailed risk assessment had not been performed. Ben Venue did, however, eventually filed a report with the local police, but handed them an empty can, and the police were unable to extract DNA or fingerprints (back story).
Given its sorry track record, a consent decree is not surprising. But Ben Venue says that more than $300 million has been invested to remediate the facility and claims progress has been made in returning the plant to full production. Whether the drugmaker can succeed in convincing the FDA that good manufacturing practices will be taken seriously, however, remains to be seen.