La Michoacana 100% Natural INC in Homestead

Specifically, observed that establishment did not registered as a food facility with the Food and Drug Administration (FDA). Operator stated that they have obtained a UFI number and is working with the FDA to obtain their Food Facility Registration number. o

Specifically, observed food establishment operating without a valid 2023 food permit. o 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, observed that operator has not submitted the required qualified facility attestation to the Food and Drug Administration (FDA). o

Specifically, observed product label for Coco Ice Cream Bars missing ingredient sweetened coconut flakes and its subingredients, and ingredient coconut concentrado D-15 and its ‘subingredients. Also, product label for Fresa Ice Cream Bars is missing ingredient strawberry red coloring and its subingredients including FD&C Red No. 40. Furthermore, in both aforementioned product labels the ‘subingredients listed for the ice cream mix are incorrect, the manufacturer address is incorrect, and the statement of identity or product name is only in the Spanish language. Inspector provided link via email for FDA's finished product labeling and a labeling guide. Product with said labels was placed under stop sale order and release. Product was voluntarily destroyed by operator and witnessed by inspector. See supplement. 99 Citation Description: The food establishment is operating without a valid food permit and has not met all Qa Permitting requirements, 500.12, F.S., 5K-4,020(2) F.A.C. Observation: Specifically, observed food establishment operating without a valid 2023 food permit. The establishment began operating over 5 years ago, as stated by person in charge. This is a tepeat violation from the report of previous inspection conducted in 10/11/2023, 117.201(a) Citation Description: Food establishment has not Submitted the required qualified facility attestation to the Oo FDA. 21 CFR 117.201(a) Observation: Specifically, observed that operator has not submitted the required qualified facility attestation to the Food and Drug Administration (FDA). This is a repeat violation from the report of previous inspection conducted in 10/11/2023. Print Date: 11/14/2023 Page 1 of 10 SAS SANT AVATAR Man cee oc Scanned by CamScanner 117.37(a) Citation Description: Plumbing not adequately sized and designed or not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant. 21 CFR 117.37(b)(2) Observation: Specifically, operator unable to provide required documentation regarding adequate sewage and liquid disposable waste conveyance. Inspector provided Water and Sewer Requirements for Food Permit and Initial Inspection form to operator via email. This is a repeat violation from the report of previous inspection conducted in 40/11/2023. 117.40 Citation Description: Food-contact surfaces not made of non-toxic materials and are not designed to withstand the environment of their intended use, the action of the food or the cleaning compounds, sanitizing agents and cleaning procedures. 21 CFR 117.40(a)(5) Observation: Specifically, mixing bucket used in the manufacture of popsicle mixtures is of non-food grade plastic. Said bucket was placed under stop use order and released. The bucket was removed from service by operator. See supplement. A Supplemental Report was also issued during the visit which includes important information for management.