Blunt Talk from the FDA on Outsourcing Operations

Jack Garvey |

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?

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 outsource manufacturing to a third-party.

Here’s where the bluntness comes in.  While the FDA acknowledged that outsourcing 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.”

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.

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


One thought on “Blunt Talk from the FDA on Outsourcing Operations

  1. I was recently an expert witness in a civil suit and watched our lawyers rip the opposing “expert” witness into little shreds. Make sure that your consultant knows their business.
    Another FYI is that if you get sued in civil court by someone alleging that you have not performed due diligence in manufacturing your FDA regulated product, GMPs are the standard that is judged against. If you’re not following the CFR, your issues with FDA are just the beginning of your troubles.

Leave a Reply

Your email address will not be published. Required fields are marked *

Time limit is exhausted. Please reload CAPTCHA.