Ben Venue Laboratories was a pharmaceutical manufacturing company based in Bedford, Ohio (a suburb of Cleveland), specializing in sterile injectable drugs and contract manufacturing.

Raymond Templeton Smith was the executive vice-president of Pittsburgh Coal; he reported to Andrew Mellon. Smith wanted to have his own business. When his father-in law’s (Julian Kenendy) will was finally settled and the bequests disbursed, he had capital to finance a new venture.

One person approached him with the idea of extracting vitamins from alfalfa. Smith considered that, but a doctor from Cleveland Clinic approached him and said that it would be far more lucrative to produce pharmaceuticals. Smith chose to pursue that line. That the doctor was at the Cleveland Clinic explains why the company was established in 1938 in Cleveland, rather than Pittsburgh, where Smith lived.

Ben Venue pursued various lines of manufacture. It used the freeze-drying techniques (lyophilization) that had been invented at the beginning of the twentieth century . This enabled Ben Venue to be one of the few companies to freeze dry plasma for American soldiers during World War II; for this work, Smith was invited to the White House.

Ben Venue also specialized in processing human growth hormones. At that time, the source of such hormones was the urine of pregnant mares. Smith sister, Helen, helped by sewing diapers for mares. Once a company employee was driving a tanker filled with mare’s urine when the police stopped him. The police asked what was in the tank; when the driver told him, he arrested the driver. A call to the company was necessary to straighten out the matter.

When Kennedy Smith took over management, Ben Venue continued to specialize in small batches of hard to manufacture drugs, including experimental oncological drugs for the NIH. As Kennedy Smith’s health deteriorated, his son Edward C. Smith took over management. The company was known in the pharmaceutical industry for its devotion to quality and sterility.

In 1997, Ben Venue was purchased by the German pharmaceutical company Boehringer Ingelheim, becoming a key part of their operations for generic injectables and contract manufacturing services. The price was in the mid-nine figures.

Under Boehringer Ingelheim, Ben Venue grew into a significant facility with multiple manufacturing plants and a Quality and Development Center. At its peak, it employed around 1,100 people and contributed substantially to the local economy in Bedford (e.g., generating over 20% of the city's operating budget through taxes at one point). The company produced critical drugs, including injectables for cancer treatment and other therapies (notably involved in producing Doxil, a liposomal doxorubicin formulation).

However, the facility faced significant regulatory challenges starting in the 2000s. The FDA conducted numerous inspections (35 since 1997), identifying persistent current Good Manufacturing Practice (cGMP) violations related to quality control, sterility, contamination risks (e.g., reports of rusty tools, mold, and other issues), and product quality. This led to nearly 40 drug recalls since 2002, with several involving serious contamination concerns.

In late 2011, following severe FDA findings, Ben Venue voluntarily shut down manufacturing and distribution operations temporarily to address the issues. The company invested heavily (around $300 million) in remediation efforts, and limited production resumed in late 2012.

Despite these attempts, the problems persisted. In January 2013, a U.S. District Court entered a consent decree of permanent injunction against Ben Venue Laboratories, its parent Boehringer Ingelheim, and senior executives, mandating strict compliance measures due to ongoing noncompliance.

Ultimately, Boehringer Ingelheim decided the facility could not return to sustainable, compliant production. In October 2013, Ben Venue announced it would cease all production by the end of 2013, resulting in the layoff of approximately 1,100 employees (phased through 2014). Manufacturing fully halted in December 2013.

Post-closure:

In 2014, Hikma Pharmaceuticals acquired substantially all assets of the Bedford site from Ben Venue/Boehringer Ingelheim, with plans to potentially reactivate parts for manufacturing and add R&D capabilities.

In 2015, Hikma sold the facilities to Xellia Pharmaceuticals (a Danish company), which intended to reopen portions and bring back around 170 jobs. The site has since operated under new ownership, separate from the original Ben Venue entity.