I’ve read a lot of Warning Letters in my 30 years of working in FDA-regulated industry.  But one issued this week made me stop and think:  is the FDA getting blunter in its language?

Warning Letter & Response

The Warning Letter was issued by FDA’s Office of Pharmaceutical Quality Operations to a Florida-based OTC manufacturer on December 3 and released to the FDA’s website on January 12.

In short, the manufacturer was cited in the 483 and Warning Letter with a slew of serious violations.

The company’s response to the investigator during the inspection and through the 483 rely was that they were going to stop manufacturing in-house and start outsourcing operations for manufacturing to a third-party.

FDA Response

Here’s where the bluntness comes in.  While the FDA acknowledged that outsourcing operations is common, they told the Florida manufacturer in no uncertain terms:

“FDA regards contractors as extensions of the manufacturer.”

And if that wasn’t clear enough,

“If you plan to engage in the use of contract facilities, you are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.”

Quality Agreements Article

This Warning Letter reminded me a great article that Compliance Architects’^® Practice Director, Teresa Gorecki wrote entitled: “Quality Agreements – Cornerstone of Product Supply Relationships.”

Here’s a link to the article.  Like the FDA’s bluntness, Teresa provides this insightful comment: “You can delegate your responsibilities, but you can never delegate your accountabilities.”

If you’re interested in a roadmap for how to effectively outsource — or manage existing outsourced relationships — this article is a must read.

Contact Us

If you’re considering outsourcing operations, or struggling with managing your current contractors, don’t hesitate to reach out to Jeff Grizzel, VP of Business Development, 703-587-8990, jeff.grizzel@compliancearchiects.com.