Someone at Nippon Fine Chemical must have been very nervous when an investigator from the US Food and Drug Administration arrived last year.
In an unusual display of chutzpah, the drug and ingredients maker refused to allow the investigator to inspect its quality control laboratory at its facility in Hyogo, Japan. Employees literally formed a “shoulder-to-shoulder” barricade to prevent the FDA employee from entering, according to a Sept. 26 warning letter that summarized the visit of the abbreviated inspection that occurred last December.
If this gives you pause, keep reading.
During the inspection, the FDA investigator reviewed customer complaints that Nippon drugs contained glass, hair, cardboard, metal — and even a black spider. But Nippon employees refused to provide the investigator with copies of documents that detailed customer complaints. The FDA letter noted that Nippon uses the same equipment and processes for drugs sold in the Japanese and US markets.
To top it off, the Nippon quality assurance manager prevented the investigator from taking photos of equipment used to make drugs that are distributed to the United States. The FDA letter suggests that, in this case, quality assurance may have been an oxymoron.
As a result of these foibles, the FDA declared Nippon products to be adulterated and issued an import alert two months ago, an action that means Nippon products can be detained from entering the US.
Nippon could not be reached for comment.
The FDA response is not surprising.
The agency has previously noted that refusing to permit inspectors to enter a facility or examine certain specified records violates federal law. And after encountering a growing number of recalcitrant companies, some of which simply tried to use delaying tactics to thwart inspections, the FDA issued a guidance two years ago to make clear such moves would have consequences.
The pharmaceutical industry has raised concerns about some aspects of the guidance. In an essay last year, attorneys at Hyman, Phelps & McNamara, which specializes in regulatory matters, noted that Congress “never explicitly empowered FDA to take photographs” and that federal law does not empower the agency to require any employee to answer questions during an inspection.
Nonetheless, the guidance emerged amid growing concern about the quality of the pharmaceutical supply chain. In 2008, for instance, there was a recall of the heparin blood thinner, which was made with a fake Chinese active ingredient and linked to 246 deaths in the US. China is now the world’s largest supplier of active pharmaceutical ingredients.
In India, Ranbaxy Laboratories, which was one of the largest suppliers of generic drugs to the US, paid $500 million in fines and restitution to US authorities as part of a settlement that included pleading guilty to charges of violating drug safety laws. These episodes have raised widespread concerns about quality control. To crack down, the FDA has moved to hire additional inspectors in both countries.