Inspections, Compliance, Enforcement, and Criminal Investigations

Charanga Catering, LLC dba Broche 3 8/28/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-27
August 28, 2014
Charanga Catering, LLC dba Broche 3
Mr. Gilberto Broche
President and Owner
233 W. 28th Street
Hialeah, FL 33010
 
Dear Mr. Broche:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat food and seafood processing facility, located at 233 W. 28th Street Hialeah, FL 33010 from May 23, 2014 through July 02, 2014. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and  the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).  In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 342(a)(4)]. In addition, failure to comply with the requirements of Part 110, renders all of your products, both fishery and non-fishery products adulterated within the meaning of Section 402(a)(4) of the Act.
 
Accordingly, your fried swai fillets, baked salmon fillets, mixed seafood ceviche, and your non-fishery ready-to-eat food products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, the current 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance, and CGMP regulations for food through links in FDA's home page at www.fda.gov.
 
We acknowledge the receipt of your written response letter dated July 15, 2014. The agency has reviewed your response, and we continue to have concerns because you have not provided detailed evidence or documentation of your reported corrections.Our evaluation of your written response in relation to each violation is discussed below.
 
Your significant violations were as follows:
 
HACCP Violations
 
1.    You must conduct or have conducted a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards which are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). Your firm does not have HACCP plans for the following products:
 
a)    You do not have a HACCP plan for fried swai fillets packed in plastic wrapped aluminum trays to control the hazards of allergens, pathogen growth due to time/temperature abuse, and pathogen survival through cooking.
 
b)    You do not have a HACCP plan for baked salmon fillets packed in plastic wrapped aluminum trays to control the hazards of allergens, pathogen growth due to time/temperature abuse, and pathogen survival through cooking.
 
c)    You do not have a HACCP plan for mixed seafood ceviche (cooked shrimp, imitation crab meat, octopus, surimi, squid, and mussels) packed in plastic containers with plastic lids to control the hazards of allergens, parasites, and pathogen growth due to time/temperature abuse.
 
We have reviewed your response and determined it to be inadequate. In your response you state that you have an incomplete HACCP plan for your fishery products and that you are currently performing a hazard analysis of all your fishery products. However, you have not provided documentation of your current HACCP plan or a timeline for the completion of your hazard analysis. Additionally, an incomplete HACCP plan is not an adequate correction to address this violation. 
 
Please be advised that in accordance with 21 CFR 123.6(b)(2) your firm may group kinds of fish and fishery products together, or group kinds of production methods together if the food safety hazards, critical control points, critical limits and procedures identified are identical.
 
2.    You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, and with 21 CFR 123.11(b). Your did not monitor the safety of water that comes in contact with food; the maintenance of hand washing and hand sanitizing areas, the condition and cleanliness of food contact surfaces; the prevention of cross-contamination of food from insanitary objects; protection of food and food contact surfaces from adulteration with condensate; the exclusion of pests; and the proper labeling, storage and use of toxic chemicals with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
a)    On 05/23/14, no backflow devices were noted throughout the firm on the hose bibs that supply water used for manufacturing food and the cleaning of food contact surfaces and equipment.
 
b)    On 05/23/14, no hot water was observed at the hand washing sinks in the bakery, prepared food, and food display areas.
 
c)    On 05/23/14 and 05/27/14, no towels or suitable hand drying devices were observed at the hand washing sinks in the kitchen, prep room, bakery, and prepared food areas.
 
d)    On 05/23/14, 05/27/14, and 05/28 – 29/14, numerous employee food and personal items including but not limited to beverage containers, a car key, a phone charger, and a purse were observed throughout the firm directly adjacent to and within the immediate vicinity of exposed food, raw materials, and production equipment.
 
e)    On 05/23/14, stagnant water was noted on the floor in the FDA processing and packing area next to ready-to-eat, cooked and prepared foods stored on baking trays.
 
f)    On 05/28/14, employees in the bakery area were observed handling several types of cooked, ready-to-eat foods without washing and/or sanitizing their hands in between tasks.
 
g)    On 05/28/14, condensate was observed dripping from overhead ventilation covers directly onto cooked, ready-to-eat foods in the prepared foods, preparation, and display areas.
 
h)    On 05/23/14, an employee was observed preparing a chlorine sanitizing solution during the cleaning of utensils and metal food trays without proper chlorine based sanitizer test strips. The concentration of the solution was measured with FDA chlorine test strips and was determined to be less than 50 ppm.
 
i)    On 05/23/14, live flying insects and other crawling insects were observed throughout the production in the kitchen, prep room, prepared food, and food storage areas on production equipment, food contact surfaces, and non-food contact surfaces. Numerous flying insects were also noted in these areas on 05/27/14, 05/28/14, and 05/29/14.   
 
We reviewed your response to the FDA 483 in relation to the items within this violation. We acknowledge the reported sanitation corrections, the retraining of employees, the maintenance of storage coolers, and the change in food storage practices. However, we find that your response does not fully address our concerns and is inadequate. You have not provided documentation of employee training to prevent reoccurrence of the sanitation/employee practices violations and you have not provided recent sanitation monitoring records as evidence of corrections.
 
CGMP Violations
 
3.    You must take effective measures to exclude pests from the processing areas of your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). During the inspection, FDA collected samples of apparent rodent excreta pellets from the dry goods storage area on the southeast side of your facility; the floor along the western wall of the bakery area; and the dry goods storage area on the western side of your facility. The laboratory analyses of these samples confirmed rodent filth in food processing and food storage areas of your facility. Your failure to exclude pest is also evidenced by:
 
a)    On 05/23/14, approximately twenty (20) live flying insects were noted in the pastry production area landing directly on pastry dough, guava filling, and processing equipment.
 
b)    On 05/27/14, approximately five (5) live flying insects and one (1) live bird were observed in the bakery prepared foods and display area. The bird was observed approximately three feet from a storage rack containing uncovered raisin muffins.
 
c)    On 05/29/14, approximately seven (7) live flying insects were observed landing directly on sandwich bread and processing equipment in the pastry production area.
 
d)    On 05/29/14, one (1) live insect was observed crawling on a bread rack containing uncovered bread in the pastry production area.
 
We reviewed your response to the FDA 483 in relation to the noted items within this violation. It appears you are working to correct the deficiencies observed during the inspection; however you did not provide sanitation and/or maintenance records to document the corrections you reported. All corrective actions you reported for this violation will be evaluated and verified during the next scheduled inspection of your facility.
 
4.    You must hold foods that can support the rapid growth of undesirable microorganisms in a manner that prevents the food from becoming adulterated within the meaning of the Act, to comply with 21 CFR 110.80(b)(3). However, the cold holding and storage temperatures at your facility are consistently above 40oF and do not effectively control pathogenic bacteria growth and toxin formation. Our investigators documented the following ambient air temperatures of coolers and internal temperatures of food:
 
a)    A lot of cooked pasta stored in a large plastic tote in the FDA walk-in cooler (b)(4) had an internal temperature of 67.4°F at 1:25 pm on 05/28/14. On 05/29/14 at 12:27 am, the same lot of cooked pasta stored in this cooler had an internal temperature of 48.6°F.
 
b)    A lot of prepared ceviche stored in a large plastic tote, in the FDA walk-in cooler (b)(4) at an internal temperature of 51.1 °F at 1:29 pm on 05/28/14. The same lot of ceviche was packed into 8 oz. size plastic containers and placed in the reach-in display cooler located in the prepared foods, preparation area.   On 05/29/14 at 1:01 am, this same lot of ceviche stored in the reach-in display cooler had an internal temperature of 64.4°F.
 
c)    A lot of cooked black beans stored in a large plastic tote in the FDA walk-in cooler (b)(4) had an internal temperature of 55.2°F at 1:26 pm on 05/28/14. On 05/29/14 at 12:29 am the same lot of black beans stored in this cooler had an internal temperature of 48.8°F.
 
d)    A lot of brown gravy stored in a five gallon plastic bucket in the FDA walk-in cooler (b)(4) had an internal temperature of 72.6°F at 1:34 pm on 05/28/14.   On 05/29/14 at 12:32 am the same lot of brown gravy stored in this cooler had an internal temperature of 64.2°F.
 
e)    The ambient air temperature of the FDA walk-in cooler (b)(4) where cooked ready-to-eat foods are stored was 47.1 °F at 12:14 pm on 05/27/14; 46.9°F at 1:38 pm on 05/28/14; and 48.8°F at 12:40 am on 05/29/14.
 
f)    The ambient air temperature in the open refrigerated display case in the prepared foods, preparation, and display area where cooked ready-to-eat foods are stored was 68.2°F at 12:06 pm on 05/28/14.
 
g)    The ambient air temperature in the FDA walk-in cooler (b)(4) where cooked ready-to-eat foods are stored was 52.5°F at 12:47 am on 05/29/14.
 
We reviewed your response to the FDA 483 in relation to the noted items within this violation. The adequacy of your reported corrections for this violation cannot be determined. We acknowledge your reported correction of maintenance performed on the storage coolers to ensure the temperatures are below 40oF. However, you should did not state how you would monitor temperatures in your cold storage and you did not state your corrective action plan for what happens if a cold storage area exceeds your storage temperature limit.
 
Please be advised that your cold storage temperature limits must be appropriate for both your non-fishery and fishery products and in accordance with your hazard analysis for each product or product group.  All corrective actions you reported for this violation will be evaluated and verified during the next scheduled inspection of your facility.
 
5.    You must conduct all food manufacturing, including packaging and storage, under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). However, your current production procedures may contribute to contamination. For example, our investigators observed:
 
a)    A wooden preparation table used to store pastry dough and prepare sandwiches in the FDA pastry production area contained visible filth and old food residue throughout the inspection on 05/23/14, 05/27/14, and 05/29/14.
 
b)    Rolling pins used to flatten dough in the pastry production area contained encrusted residue and visible filth throughout the inspection on 05/23/14, 05/27/14, and 05/29/14.
 
c)    A mixer in the bakery area exhibited encrusted food residue and visible filth on food contact surfaces during the mixing of dough on 05/27/14 and 05/29/14.
 
d)    On 05/29/14, a sandwich press in the bakery area exhibited visible filth and rust during the manufacturing of sandwiches.
 
e)    On 05/27/14, dough was observed in direct contact with processing equipment exhibiting rust and flaking paint in the bakery area.
 
f)    On 05/23/14, 05/27/14, and 05/29/14, pastry dough and baked bread were observed in direct contact with a wooden preparation table with visible filth and old food residue in the pastry production area.
 
g)    On 05/28/14, visible filth and encrusted residue was observed on storage racks inside the FDA walk-in cooler (b)(4) directly above an open container of brown gravy.
 
h)    On 05/28/14, tortillas were observed in direct contact with a wall exhibiting flaking paint in the prepared foods, preparation, and display area.
 
i)    On 05/28/14, a fly trap was installed directly above a cart containing seasoning in the USDA kitchen.
 
We reviewed your response to the FDA 483 in relation to the items within this violation. The adequacy of your reported corrections for this observation cannot be determined. We acknowledge the reported correction of overall general sanitation and retraining of employees on sanitation practices.  However, you did not provide documentation of your reported corrective actions.  All corrective actions you reported for this violation will be evaluated and verified during the next scheduled inspection of your facility.
 
6.    You must maintain the construction of your plant and facilities in such a manner as to ensure the floors may be adequately cleaned and kept clean and in good repair [21 CFR 110.20(b)(4)]. In addition, you must maintain your physical facility in a sanitary condition and in sufficient repair to prevent food from becoming contaminated [21 CFR 110.35(a)]. Our investigators observed the following areas of disrepair and insanitary conditions:
 
a)    On 05/23/14,  05/27/14, and 05/28 – 05/29/14, the door to the FDA walk-in cooler (b)(4) used to store ready-to-eat, cooked and prepared foods was broken and would not close.
 
b)    On 05/23/14, 05/27/14, and 05/28 – 05/29/14, a hole in the ceiling and missing portions of the wall were observed directly above and behind a storage rack containing raw materials in the dry goods storage area.
 
c)    On 05/23/14, 05/27/14, and 05/29/14, black visible filth was observed on the floor inside the FDA walk-in freezer.
 
d)    On 05/23/14, 05/27/14, and 05/28 – 05/29/14, visible filth and encrusted residue was observed on the floor and storage racks inside the dry goods storage area and the FDA walk-in cooler (b)(4).
 
e)    On 05/23/14, 05/27/14, and 05/29/14, pitted/uneven floor surfaces were observed in the FDA walk-in freezer, dishwashing, FDA processing and packing, FDA kitchen, and FDA prep areas.
 
f)    On 05/29/14, a dark mold/mildew like substance was observed on the walls inside the FDA walk-in cooler (b)(4) and (b)(4).
 
We reviewed your response to the FDA 483 in relation to the items within this violation. The adequacy of your reported corrections for this observation cannot be determined. We acknowledge the reported correction of repairs to your facility. However, you did not provide documentation of your reported corrective actions. All corrective actions you reported for this violation will be evaluated and verified during the next scheduled inspection of your facility.
 
7.    You must store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21CFR 110.37(f).Our investigators observed the following areas harborage and scattered refuse:
 
a)    On 05/23/14, five (5) white birds were observed in the back alley on the north side of the facility, roaming around scattered waste, approximately fifteen feet from an open screen door leading directly into the pastry production area. The birds were attracted to several garbage items including but not limited to boxes, bags of trash, egg crates, and bottles.
 
b)    On 05/23/2014, five (5) white birds were observed in the parking lot on the south side of the facility, roaming around scattered waste, approximately five feet from an open bay door leading directly into the bakery area. The birds were attracted to several garbage items including but not limited to empty boxes and crates.
 
We reviewed your response to the FDA 483 in relation to the items within this violation. The adequacy of your reported corrections for this observation cannot be determined. We acknowledge the reported correction of acquiring a bigger dumpster to better accommodate refuse. However, you did not provide documentation of your reported corrective actions or a timeline for completion of this correction. All corrective actions you reported for this violation will be evaluated and verified during the next scheduled inspection of your facility.
 
8.    You must to provide, where necessary, adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Your firm failed to provide adequate screening as evidenced by: 
 
a)      The bay door in the bakery prepared foods and display area leading to the front parking lot was open and unscreened during the course of the inspection.
 
b)      A screen door in the pastry production area leading to the back alley was open during the course of the inspection.
 
c)      A bay door in the dry goods storage area exhibited an approximate 1 inch gap along the side of the door.
 
d)     An approximate 1 inch gap was observed under a screened door in the bakery area leading to the back alley.
 
We reviewed your response to the FDA 483 in relation to the items within this violation. The adequacy of your reported corrections for this observation cannot be determined. We acknowledge the reported correction of repairs to your facility. However, you did not provide documentation of your reported corrective actions. All corrective actions you reported for this violation will be evaluated and verified during the next scheduled inspection of your facility.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating. This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.    
 
Your written response should be sent to Erica M. Katherine, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751.If you have questions regarding any issues in this letter, please contact Ms. Katherine at (407) 475-4731.
 
 
Sincerely,
/S/ 
Elizabeth W. Ormond
Acting District Director
Florida District

Page Last Updated: 09/25/2014
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