The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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. Hacienda Mexican Foods LLC Detroit, MI A food firm in Michigan is on notice from the U.S.
Food and Drug Administration (FDA) for violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. In an April 4, 2024 warning letter, the FDA described an April 21, 2023, inspection of Hacienda Mexican Foods LLC’s ready-to-eat (RTE) soft wheat flour tortilla manufacturing facility located in Detroit, MI. FDA investigators determined that the company’s RTE soft flour tortillas manufactured in their facility are adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
Other observations include the firm not cleaning and sanitizing their utensils or equipment in a manner that protects against contamination of food-contact surfaces, cockroaches and more. After the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at the facility. Some of the significant violations Haza.