The U.S. Food and Drug Administration (FDA) recently posted a warning letter sent June 18, 2015, to FSS Inc. (dba, Food Service Specialties) in Red Wing, MN. FSS makes Salsa Con Queso Sauce, Cheese Dip, White Queso Sauce, and Alfredo Sauce packaged in glass jars and also manufacturers acidified food products including Alfredo sauces, snack dips and cheese sauces packaged in glass jars and flexible pouches. Other products produced by the company include high-acid, shelf-stable pasta, pizza and barbecue sauces and refrigerated, dairy-based Alfredo sauces packaged in glass jars, flexible pouches and bulk totes, the agency noted. FDA’s letter stated that an inspection of the facility on four dates in December 2014 and again on two dates in January 2015 revealed “significant deviations” from the Low-Acid Canned Foods regulations and the Acidified Foods regulations and deviations from current Good Manufacturing Practices regulations. Specifically, FDA stated that a review of records indicated that during sterilization, “the rotation speed was not electronically documented nor was it manually recorded.” Also, the letter stated, a review of the record Retort Processing Log in November 2014 indicated that the rotation speed and stopwatch time were not manually documented during sterilization. During each retort cycle, the container used to measure internal temperature of the products is nested with additional containers in an insulated cooler, which does not reflect the worst case conditions, FDA stated. The firm also failed to plainly mark with a heat-sensitive indicator, or other effective means, those units that have been retorted, according to the letter. Additional concerns stated were that the company did not perform a cold water vacuum test of the closing machine prior to the start of filling operations. Process deviations were also noted. FDA acknowledged the firm’s responses but stated that the corrections were inadequate because no adequate documented evidence to ensure compliance was provided. Finally, FDA’s letter stated the firm “failed to ensure all reasonable precautions are taken to ensure that production procedures do not contribute contamination from any source …. Specifically, effective measures are not taken to protect against the inclusion of glass in finished product.” FDA stated that on Dec. 11, 2014, the air blower in the glass jar filling room was not functioning during the manufacture of acidified product, so glass jars were not air blown or inverted prior to filling. “In addition, our investigators observed a jam on the conveyer leading to the closing machine which caused several jars to fall and break; however, the operator did not conduct a thorough inspection of the conveyor after the incident,” the letter stated. The company’s response addressed this issue but FDA stated no training details were provided and no explanation given about why the glass jars “were not handled in a safe manner.” In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law. (To sign up for a free subscription to Food Safety News, click here.)