Regulatory Focus™ > News Articles > Trend in Warning Letters Points to Crackdown on Contract Manufacturing Using Logic of Park Doctrine

Trend in Warning Letters Points to Crackdown on Contract Manufacturing Using Logic of Park Doctrine

Posted 23 May 2013 | By Alexander Gaffney, RAC

When the US Food and Drug Administration (FDA) wants to make a point, it often does so through a series of similar-sounding Warning Letters. Earlier this year, for example, the agency sent eight Warning Letters to companies at the height of the influenza season in the US, warning them about the improper claims associated with their products. In 2012, the agency sent a similar number of letters to foreign manufacturers after they failed to register their facilities with FDA.

But often times FDA's admonitions are more subtle than that. Take for example three Warning Letters sent recently to dietary supplement manufacturers Natures Health Options, Body Systems Inc, and Glucorell, Inc.

A Common Theme

All three are Florida-based companies, manufacture dietary supplements, and utilize outside third-party contract manufacturers. And, according to FDA's Warning Letters, all three are deficient in their responsibilities to oversee those same contractors.

The trouble, according to the three letters, is that the companies have outsourced the production of the products, but have not closely overseen quality of those same products. The three companies received identical warnings from FDA for this oversight.

"Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements," FDA wrote, citing the now-famous court decision of United States v. Park. That court case held that criminal wrongdoing may be proven even if a person is has delegated their responsibility to others under the theory that agents who are "vested with the responsibility, and power commensurate with that responsibility," to ensure compliance with the law have the obligation to ensure compliance.

"Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations," FDA added.

In all three cases, the failure of the companies to ensure the final quality of their products rendered them adulterated by virtue of not meeting current good manufacturing practices (CGMPs) in the eyes of FDA. Agency regulators said all three must implement process controls meant to ensure the quality of their respective products.

Written Procedures Seen as Important

In all three cases, FDA also flagged the fact that none appeared to either have or follow written procedures. "We note that you stated you will meet with your contract manufacturers to ensure that written procedures for quality control are in place; while your quality control procedure may include ensuring your contract manufacturers establish written procedures for quality control, the regulation requires your firm to establish your own quality control procedures to ensure the quality of your product that you hold and distribute," regulators wrote to Natures Health.

"You do not have a system of production and process controls to ensure the quality of your dietary supplements that you receive from your contract manufacturers and that your dietary supplement products are labeled as specified in the master manufacturing record," FDA noted in the letter to Body Systems.

Without those written procedures, FDA noted, the firms would remain out of compliance with US regulations.

Which raises a final question: Is this the start of a larger crackdown by FDA on dietary supplement manufacturers and other contractors? A search of other recent FDA Warning Letters found at least two others, sent last week to Pristine Bay LLC and Entrenet Nutritionals, with exactly the same language, bringing the current tally up to five.

If you're a dietary supplement manufacturer, then, you might want to make sure your contractors are familiar with your CGMP agreements.

Warning Letter to Natures Health Options

Warning Letter to Body Systems

Warning Letter to Glucorell

Warning Letter to Pristine Bay

Warning Letter to Entrenet Nutritionals

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