Posted 23 June 2015
By Alexander Gaffney, RAC
Some Warning Letters sent by the US Food and Drug Administration (FDA) to pharmaceutical companies are destined to become case studies, either because of the novelty of the agency's arguments or the scope or context of the alleged violation.
The agency's more famous Warning Letters include its crackdowns on search engine marketing (2009), improper use of social media channels (2013-2014), genomic testing (2013) and data integrity issues (2013-2014) at Indian pharmaceutical manufacturers.
But a letter sent this week by FDA to a South Carolina-based pharmaceutical manufacturer is an instant classic for another reason entirely: It shows how a spider can literally catch a company in a web of deceit.
The Web of Deceit
The 8 June 2015 letter to Trans Ox, a West Columbia, SC-based pharmaceutical manufacturer, references a November 2014 inspection of the company's facility by FDA.
There, FDA said it found "significant violations of current good manufacturing practice" which ultimately caused the company's products to be deemed adulterated under federal law.
The problem, as FDA explains in its letter, is that drug manufacturers are required by federal regulation (21 CFR 211.165) to test each manufactured drug product to determine if it meets the intended specifications. If, for example, a drug product was found to be more potent than intended, that would be grounds for the company to discard the product and investigate the cause of the discrepancy.
Trans Ox neglected to accurately record batch production information, FDA charged in its Warning Letter.
"During our inspection of your facility, we documented multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing or from your supplier's Certificates of Analysis (CoAs)," FDA wrote.
What tipped off FDA to these "erroneous" statements? A spider.
The company's batch production records said the company had used a specific piece of equipment—an oxygen analyzer—to analyze its products.
"However," FDA wrote, "the FDA investigator observed cobwebs between the portable Oxygen Analyzer and the adjacent wall."
Upon further questioning, a company manager said the company doesn't actually use the oxygen analyzer, directly contradicting the company's batch production records, FDA said.
Ordinarily, FDA doesn't appreciate insects in a manufacturing facility (21 CFR 211.56), but in this rare case, the agency may well have appreciated the help.