FDA puts companies on notice with warning letters

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Yost Foods, LLC. — Brunswick, OH

The Food and Drug Administration sent a warning letter dated Sept. 10, 2019, to the President of Yost Foods LLC, William Yost.

During an inspection at Yost Foods LLC Ready-to-Eat (RTE) spice manufacturing facility on March 18 through April  24, 2019, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

FDA investigators collected environmental samples from various areas in the processing facility. They also found the presence of Listeria monocytogenes. They also gathered documentation that one of the company’s customers tested and found Yost Foods LLC aji amarillo paste to be positive for L. monocytogenes. The company voluntarily recalled and destroyed the product.

The FDA received a response dated Aug. 8, 2019, to the FDA 483a FSVP observations form issued on June 28, 2019.

In response to these deviations, the FDA issued an FDA 483, Inspectional Observations report that lists deviations observed at the facility.