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FDA Threatens to Exercise New Powers

In February, 2012, the Food and Drug Administration (FDA) wrote a warning letter to a New York based seafood company. In the letter, FDA documented the company’s violations of Seafood Hazard Analysis and Critical Control Point (HAACP) requirements, citing a failure to comply with section 21 of the Code of Federal Regulations Part 123.6(g):

Failure of a processor to have and implement a HACCP plan that complies with this section whenever a HACCP plan is necessary, [or] otherwise operate in accordance with the requirements of [21 C.F.R. Part 123], shall render the fish or fishery products of that processor adulterated under section 402( a)(4) of the [Federal Food, Drug, and Cosmetic] act.

Thus, FDA deemed the seafood products adulterated and injurious to health. The seafood company apparently replied to FDA’s warning letter, but FDA deemed the response “inadequate.” FDA subsequently warned the company that FDA may take further action to seize their product(s) and/or enjoin the firm from operating unless the violations are corrected (FDA Letter).

The power to seize food products and close noncompliant facilities is a new authority bestowed upon FDA via the Food Safety Modernization Act (FSMA) of 2011. FSMA grants FDA new powers; food companies need to be sure they are aware of all new FSMA regulations. For a list of the top ten things food professionals should know about FSMA, click here.

There is much to be learned from this story. When communicating with FDA, it is prudent to have a regulatory professional communicate with FDA on your behalf. The seafood company may have avoided HAACP violation if they had sought assistance earlier. With many years of experience, Registrar Corp has helped thousands of companies all around the world comply with FDA regulations and communicate with FDA. Our team of experts stays up-to-date with FDA regulations and requirements in order to better serve the food and beverage industry.

For more information about HAACP regulations or any FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.