Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back down.”
In its Warning Letter, FDA told the ex-U.S. drug company:
During the inspection, you initially barred our investigator from accessing a room identified as a laboratory. You eventually allowed the investigator to inspect the laboratory, but he found that it contained no equipment. You then stated that the laboratory was offsite at … residence and that you could not give our investigator access as it was not a convenient time.
When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs manufactured, processed, packed, or held in the facility may be deemed adulterated under section 501(j) of the FD&C Act [Federal Food, Drug, and Cosmetic Act].
- We repeat our observations in our previous Bulletin.
- It is noteworthy that FDA placed the company and its products on Import Alert, shortly before posting the Warning Letter on its website. So, while a company can try to delay the inevitable, the agency reserves the right to refuse the entry of the company’s products into the United States.
- It is also important to recognize that denial of an FDA inspection is not limited to the facility’s entrance. Here, the company permitted the investor to enter the facility, but not to access areas to which the investigator was entitled, by law, to inspect.
- A company can try to stand its ground. It might even be appropriate, based on the facts. However, a company should pay careful consideration in keeping with the Petty theme — it may find itself “running down a dream” to sell its products in the U.S.