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].