Macy Smoked Fish and Dip in Fort Pierce

Specifically there is no evidence of current FDA Food Facility Registration. o

Specifically there was no valid food permit at the time of the inspection. o Citation Description: Food establishment has not submitted the required qualified facility attestation to the FDA. 21 CFR 117.201(a) Observation: Specifically the food establishment has not submitted a qualified facility attestation. o 117.201(a) INSPECTION: GMP-117 Violation No. 117.20(a) Citation Description and Observation COS Citation Description: Equipment not properly stored, litter and waste not properly removed, weeds or grass not cut that may constitute an attractant, breeding place or harborage area for pests within the immediate vicinity of the plant buildings or structures. 21 CFR 117.20(a)(1) Observation: Specifically there are unused plumbing fixtures and other litter and waste items stored outside of the facility near the smoker area. COS-removed litter, waste and other items from area around smoker and grounds of facility. x INSPECTION: SEAFOOD HACCP Violation No. 123.11(b) Citation Description and Observation COS Citation Description: Sanitation deficiencies not corrected in a timely manner. 21 CFR 123.11(b) Observation: Specifically observed storage of tires and other items not related to food operations in the storage room providing pest harborage conditions and impeding adequate monitoring for exclusion of pests. o Print Date: 2/16/2024 Page 1 of 4 123.6(c) Citation Description: Verification procedures and/or frequencies listed in the HACCP plan are not sufficient to ensure that the HACCP plan is adequate to control food safety hazards, and is being effectively implemented. 21 CFR 123.6(c)(6) Observation: Specifically the HACCP plan does not include in the verification procedures calibration of process monitoring instruments. In practice a log is kept documenting calibration of the metal stem thermometer to measure internal temperature of product at the smoking and cooling ccps. o 123.6(c) Citation Description: Corrective action plan listed in the HACCP plan is not in accordance with 21 CFR 123.7(b) to ensure affected product is not entered into commerce and /or the cause of the deviation was corrected. 21 CFR 123.6(c)(5) Observation: Specifically the corrective actions of "Put the name of the fish on label of container" at the labeling ccp to control the hazard of undeclared food allergens; "maintain cooler temp" at the brining ccp to control the hazard of scombrotoxin; "hold for eval if temp reduction not achieved" at the cooling ccp to control the hazards of pathogen growth and toxin formation and scombrotoxin formation; "maintain at least 40*f in cooler" at the brining ccp to control the hazard of scombrotoxin formation are not sufficient to ensure that affected product does not enter commerce and/or the cause of the deviation was corrected. o 123.6(c) Citation Description: HACCP plan lists monitoring procedures and/or frequencies that do not adequately ensure a critical limit is met. 21 CFR 123.6(c)(4) Observation: Specifically at the "smoking/cooking" ccp the monitoring procedure of "cook time and temp before removal from oven with a thermometer and at least once before the final temp check has been met to remove product" does not ensure the hazard of pathogen survival through cooking (Listeria monocytogenes) has been controlled. The monitoring procedure of "cooler temp/visually/every time brining occurs" is not sufficient to control the hazard of scombrotoxin formation at the brining ccp. The monitoring procedure of "cooler temp/check temp 3 times daily and record" is not sufficient to ensure control of the hazard of pathogen growth and toxin formation at the storage ccp. In practice the cooler temperature at the brining and storage ccps are monitored with a continuous temperature monitoring device. The temperature of the cooler was monitored at 36*f (020724) 36*f and 38*f (021424) during the inspection. o 123.6(c) Citation Description: HACCP plan does not list one or more food safety hazards that are reasonably likely to occur. 21 CFR 123.6(c)(1) Observation: Specifically the hazard of metal inclusion is not identified at the processing ccp. In practice condition checks of the buffalo chopper are conducted and a record of the check is maintained. The hazard of pathogen survival through cooking (Listeria monocytogenes) is not identified at the smoking/cooking ccp. o 123.8(a) Citation Description: Review of critical control point monitoring records not adequate to ensure that the records are complete and/or verify that they document values that are within critical limits. 21 CFR 123.8(a) (3)(i) Observation: Specifically the entries from 09/26/2022-01/23/2023, 02/20/2023 to 05/16/2023, 06/13/2023-10/03/2023, 10/31/2023-01/23/2024 in the cooking logs were not reviewed within a week of generation. o 123.8(a) Citation Description: Verification procedures do not include, at a minimum, a review of any consumer complaints. 21 CFR 123.8(a)(2) Observation: Specifically the HACCP plan does not list a review of consumer complaints as a verification procedure. o 123.9(a) Citation Description: Records do not include all of the information required by the regulation. 21 CFR 123.9(a) Observation: Specifically the smoking logs for 02/20/2023 through 01/30/2024 do not record the time the final temperature check was made. The cooling logs from 01/18/2022 to 01/30/2024 do not include the time the temperature observations were made. The brining logs from 03/19/2023 to 05/15/2023 do not list a brine start time. o