Tres Leches Factory in Doral

Specifically, food establishment has not registered as a food facility with the FDA. o

Specifically, master label for Tres Leches is missing product's identity in English and the sub-ingredients for the enriched wheat flour, evaporated milk, condensed milk and cream. Also, need to specify what type of cream is used, and is missing corn syrup as well as an ingredient. Please email correction label to [email protected]. Furthermore, multiple containers in the processing area, missing the product's identity name of the contents inside the container, such as sugar, caramel. o 117.10 Citation Description: Employee did not remove all unsecured jewelry and other objects that might fall into food, equipment, or containers, or remove hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials. 21 CFR 117.10(b)(4) Observation: Specifically, observed employees in the processing area wearing bracelets and earrings, handling ready-to-eat products, that might fall into food, equipment, or containers. o 117.10 Citation Description: Clothing or other personal belongings stored in areas where food is exposed or where equipment or utensils are washed. 21 CFR 117.10(b)(7) Observation: Specifically, employees personal bags and water bottle were stored under the processing table shelf, next to raw ingredients. o Print Date: 6/2/2023 Page 1 of 3 117.201(a) Citation Description: Food establishment has not submitted the required qualified facility attestation to the FDA. 21 CFR 117.201(a) Observation: Specifically, food establishment has not submitted the required facility attestation to the FDA. o 117.35(c) Citation Description: Effective measures are not being taken to exclude pests from the manufacturing, processing, packing and holding areas and to protect against the contamination of food on the premises by pests. 21 CFR 117.35(c) Observation: Specifically, observed two flies flying in the processing area where Tres Leches are being made, measures are not being taken to exclude pests from the processing area to protect against the contamination of food; no food was compromised. o 117.37(a) Citation Description: Hand-washing facilities not designed to ensure that an employees hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials. 21 CFR 117.37(e) Observation: Specifically, observed in the processing area, hand sink missing paper towels and hand sanitizer; restroom by office is missing hand washing sign; not designed to ensure that employees hands are not a source of contamination of food, food-contact surface of food-packaging materials. o 117.4 Citation Description: Records documenting training of qualified individuals not available. 21 CFR 117.4(d) Observation: Specifically, food establishment was not able to provide employee training records of qualified individuals on the Principles of Food Safety, Food Hygiene, and Employee Health. o 117.93 Citation Description: Storage and transportation of food, including ingredients, not under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of food, as well as against deterioration of the food and the container. 21 CFR 117.93 Observation: Specifically, observed in processing area, pitcher with raw liquid eggs stored over heavy cream in the refrigerator; also, boxes labeled caramel and plastic cups stored directly on the floor, not protected against allergen cross-contact and against biological, chemical, and physical contamination of food as well as against deterioration of the food and the container. o