You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good manufacturing practice requirements for combination products, drugs, and medical devices. The Warning Letter included a myriad of quality-related concerns, including inadequate investigations, poorly written procedures for complaint handling, and failure to establish and maintain procedures for device design verification and validation. The agency requested that the company schedule a regulatory meeting; being beckoned to the principal’s office is not a good sign.

What we focus on in this Bulletin is the reference to quality agreements. Specifically, FDA noted that the company and its customer operated under a quality agreement regarding the manufacture of the products. However, the agency stated:




You are responsible for the quality of combination products you produce as a contract facility, regardless of agreements in place with … [the customer] or with any of your suppliers. You are required to ensure that your combination products are compliant with CGMP [current Good Manufacturing Practice] requirements applicable to each manufacturing process that occurs at your facility.


FDA referred to its guidance document on “Contract Manufacturing Arrangements for Drugs: Quality Agreements.”

AGG Observations


    1. We have written about FDA’s guidance document and the value of quality agreements.


    1. Quality agreements are not legally required, but are recommended. However, as we remind clients, and FDA stated clearly in the Warning Letter, a quality agreement does not absolve a company from complying with its regulatory requirements. One cannot pass the buck.


  1. In addition to having quality agreements in place, companies should audit and monitor contractors and suppliers for compliance. An agreement, without follow up and proper execution, is merely a piece of paper. To paraphrase the classic Seinfeld line: anyone can enter into a quality agreement; it’s the “hold” (or execution) that’s most important.