Less familiarity between FDA investigators and management at medical device manufacturing plants may mean fewer recalls down the road, research in the journal Manufacturing & Service Operations Management suggests.
The authors looked at outcomes of nearly 4,800 FDA plant inspections as well as almost 2,900 recalls linked to more than 2,200 plants.
The second time the same investigator inspected a plant, the risk of a future recall grew by 21 percent. The risk rose by 57 percent after the investigator’s third inspection of the same plant, according to the authors, who are from Indiana University, the University of Minnesota and the University of Wisconsin-Madison.
“These increased recall risks may be symptomatic of increased familiarity between plant management and a repeat investigator, enabling the plant to relax its standards,” Enno Siemsen, Executive Director of the Erdman Center for Operations & Technology Management at the University of Wisconsin-Madison, stated in a news release about the research.
Putting investigators on a rotating schedule with regard to the plants they inspect could yield an estimated annual reduction of 100 medical device recalls, the authors concluded.
“Our findings demonstrate that the FDA and likely other federal regulators must navigate a fine line in their relationships with industry managers,” said Rachna Shah, Associate Professor in the Supply Chain and Operations Department at the University of Minnesota’s Carlson School of Management.