Inspections, Compliance, Enforcement, and Criminal Investigations

F. Rozzo & Sons, Inc. 8/21/17

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations East
Division 1

 
 

 

WARNING LETTER
CMS# 534445
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
August 21, 2017
 
Mr. Louis Rozzo, President/ Co-owner
F. Rozzo & Sons, Inc.
159 9th Avenue
New York, NY 10011-4903
 
Dear Mr. Rozzo:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing and distribution establishment located at 159 9th Avenue New York, NY 10011, on June 20, 22 and 29, 2017. During the inspection, our FDA investigator observed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods,  Title 21, Code of Federal Regulations (CFR), Part 110 [21 CFR Part 110].
 
We acknowledge receipt of your electronic mail, dated July 20, 2017 responding to the FDA 483, Inspection Observations (FDA 483), issued to you on June 29, 2017. We provide comments to your response immediately following the violations addressed below.  
 
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). Accordingly, your fresh yellowfin tuna loins, refrigerated ready-to-eat vacuum packed cold smoked salmon and refrigerated ready-to-eat pasteurized crabmeat are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. 
 
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.
 
Your significant deviations are as follows:
 
1.    You must implement the monitoring procedures and frequency which you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring, recordkeeping and verification procedures included in your HACCP plans as follows:
 
A.  You are not following your monitoring procedure of (b)(4) at the Receiving CCP listed in your HACCP plans for refrigerated “Smoked Product & Ready Eat Product” and “Pasteurized/Fresh Crab Meat” in order to control the food safety hazards of Clostridium botulinum and pathogen growth and toxin formation. You do not monitor or have records to show that the products were not temperature abused during transit and have no controls in place for the receipt of products.
 
B.  You are not following your monitoring procedure of (b)(4) at the Receiving CCP listed in your HACCP plan for “Histamine Fish” in order to control the food safety hazard of Scombrotoxin (Histamine) formation.
 
C.  You are not following your monitoring procedure of (b)(4) at the Refrigerated Storage CCP listed in your HACCP plans for refrigerated “Smoked Product & Ready Eat Product”” and “Pasteurized/Fresh Crab Meat” in order to control the food safety hazards of Clostridium botulinum and pathogen growth and toxin formation. These products are not stored on ice and you do not have continuous monitoring of the temperature in your walk in cooler where the product is stored.
 
D.  You are not following your monitoring procedure of (b)(4) at the Refrigerated Storage CCP listed in your HACCP plan for “Histamine Fish” in order to control the food safety hazard of Scombrotoxin (Histamine) formation. You do not have continuous monitoring of the temperature in your walk in cooler where the product is stored and you do not conduct any ice checks for histamine fish that are stored on ice.
 
E.  You are not following your monitoring procedure of (b)(4) at the Thawing/Trimming/Filleting/Packing CCP listed in your HACCP plan for “Histamine Fish” in order to control the food safety hazard of Scombrotoxin (Histamine) formation. You do not have continuous monitoring of the temperature in your walk in cooler where the product is processed (trimmed/filleted/packed) and you do not conduct any ice checks for histamine fish that are stored on ice.
 
We acknowledge your FDA 483 response dated July 20, 2017, however we are unable to evaluate the adequacy of your corrective actions. Your firm has multiple coolers and a freezer. Your response does not clarify the coverage area(s) of the continuous monitoring temperature stick your firm purchased. Your response lacks evidence to demonstrate the continuous temperature monitoring and verification has been implemented.
 
Also, we acknowledge your FDA 483 response included Histamine Temperature Reports covering receipt of Scombrotoxin (Histamine) producing fish or fishery products from a period of June 19, 2017 to July 20, 2017 however these Histamine Temperature Reports do not document verification of ice or review of truck temperature recorder chart.
 
Additionally, we acknowledge your firm’s FDA 483 response provided processing cooler temperature records from September 2016 to July 2017; however the records show a frequency of monitoring as (b)(4) which is less than the frequency noted in your firm’s HACCP Plan for “Histamine Fish”. According to the Fish and Fishery Products Hazard and Control 4th Edition, monitoring frequency during processing for exposure time is at least every 2 hours AND for temperature measurements: for a continuous temperature-recording device: continuous monitoring during processing is accomplished by the device itself with a visual check of the device at least once per lot or batch, but no less often than once per day; OR if using a temperature-indicating device at least every 2 hours.
 
2.    Because you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan listed for your  “Smoked Product & Ready Eat Product” and “Pasteurized/Fresh Crab Meat” HACCP plans at the Refrigerated Storage critical control point and your corrective action plan listed for your “Histamine Fish” HACCP plan at the Receiving critical control point are not appropriate as follows:
 
A.  Your HACCP plans for “Smoked Product & Ready Eat Product” and “Pasteurized/Fresh Crab Meat” list a critical limit of, (b)(4) at the Refrigerated Storage CCP for the significant hazard of Clostridium botulinum and pathogen growth and toxin formation. These HACCP plans at the Refrigerated Storage CCP list a corrective action procedure of “(b)(4). Your corrective action plans are not appropriate as they do not address deviations from your critical limit for temperatures between (b)(4) and they do not address the root cause of the deviation.
 
B.  Your HACCP plan for “Histamine Fish” lists a corrective action plan of (b)(4) at the Receiving CCP. This corrective action is inadequate as it does not address the root cause of the deviation.
 
We acknowledge your firm’s promised corrective action of dedicating an employee to oversee your firm’s HACCP plans implementation after the employee receives seafood HACCP training. We also acknowledge your firm’s promised corrective action of having an outside consultant assist with revising and implementing HACCP plans however no revised HACCP plans have been provided. 
 
3.    Your HACCP plans must list verification procedures with frequencies that have been developed in accordance with 21 CFR 123.8(a) to comply with 21 CFR 123.6 (c)(6).  Your firm’s HACCP plans for “Smoked Product & Ready Eat Product”, “Pasteurized/Fresh Crab Meat”, and “Histamine Fish” list verification procedures with frequencies that do not ensure that your HACCP plans are adequate to control food safety hazards as follows:
 
A.  Your HACCP plan for “Smoked Product & Ready Eat Product” lists a verification procedure of (b)(4) at the Refrigerated Storage CCP. This procedure does not include calibration of continuous temperature monitoring and recording device and does not include a daily accuracy and operational check of the device.
 
B.  Your HACCP plan for “Pasteurized/Fresh Crab Meat” lists a verification procedure of (b)(4) and “(b)(4) at the Refrigerated Storage CCP. This procedure does not include calibration of continuous temperature monitoring and recording device.
 
C.  Your HACCP plan for “Histamine Fish” lists a verification procedure of (b)(4) at the Receiving CCP, Refrigerated Storage CCP and Thawing/Trimming/Filleting/Packing CCP. This procedure does not include calibration of continuous temperature monitoring and recording device and does not include accuracy and operational check of the device.
 
We also acknowledge your firm’s promised corrective action of having an outside consultant assist with revising and implementing HACCP plans however no revised HACCP plans have been provided. 
 
4.    You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110 to comply with 21 CFR 123.11(b).  However, you did not monitor the condition and cleanliness of food contact surfaces, prevent cross-contamination from insanitary objects, ensure the maintenance of hand washing, hand sanitizing, and toilet facilities, or ensure the protection of food, and food contact surfaces from adulteration, as evidenced by the following conditions and practices observed on June 20, 2017 and June 22, 2017:
  • Condensate drip was observed from a soiled green rag hanging on a pipe connected to the condenser fan and dripping directly onto a pile of exposed black sea bass stored on the fish descaling production table in the processing room
  • Open and exposed containers with black seabass were stored directly on the wet processing room floor (after they were previously scaled, cleaned, and ready for sale). Backsplash from the wet processing room floor was observed splashing from the floor and directly onto these open and exposed containers of black sea bass. An employee was observed throwing small buckets of water onto black sea bass on the fish descaling production table above the open and exposed containers of black sea bass stored on the floor which then caused the water to splash onto the floor and then directly onto the product.
  • The red shovel used to scoop ice from the ice machine was stored directly on the wet floor in front of the ice machine. The ice is used to cover exposed fish during storage and distribution.
  • Exposed glass light bulbs (3) were observed hanging from the ceiling and located directly above the fish cutting stations in the processing room where exposed fish are cut and processed.
  • Ice used to cover the fresh fish during storage and transportation was observed stored directly touching the floor of the facility and directly touching the wheels of a trash bin that is wheeled inside and outside of the facility. In addition the Styrofoam cooler chest top that you are currently using as the door for the ice machine is porous and is not easy to clean or sanitize.
  • Clear liquid substance was observed dripping off of the top of the ice machine, down the outside of the ice machine, and directly onto a pile of uncovered ice stored in front of the opening to ice machine.
  • Condensate drip was observed from the seam on a rusted area of the ceiling and directly onto a closed cardboard box of tuna loins in your cooler storage room next to the walk-in freezer.
  • Residue build up was observed in the processing room on a rusted metal rack on a shelf directly above exposed fish that are cut on a production table.
  • Condensate drip was observed from a condenser fan on the ceiling of the processing room and directly dripping onto the scaling and fish cleaning table where exposed fish are descaled.
  • Heavy accumulation of fish debris was observed in an open crevice on the wall to the right of the fish descaling table in the fish processing room.
  • An employee’s glass beverage bottle was observed on a shelf directly above exposed fish that were being cut and processed in the processing room. 
We acknowledge your firm’s FDA 483 response dated July 20, 2017, which included the lease of an additional ice machine and your firm’s promised correction to have coolers completely replaced with new refrigeration systems installed. However your response is inadequate in that these corrective actions remain in progress and no immediate corrective actions have been taken to resolve the deficiencies until the in progress corrective actions can be completed. Additionally, your response does not address employee practices.
 
5.    Your HACCP plan shall be signed and dated at least annually to comply with 123.6 (d). However, your HACCP plans for “Smoked Product & Ready Eat Product”, “Pasteurized/Fresh Crab Meat”, and “Histamine Fish” are not being reviewed, signed, and dated at least annually. The last time these HACCP plans were signed and dated was on June 14, 2012.
 
Your firm’s FDA 483 response which was dated July 20, 2017, does not include any proposed corrective actions addressing this violation.
 
General Comment:
 
During our review of your “Smoked Product & Ready Eat Product”, “Pasteurized/Fresh Crab Meat”, and “Histamine Fish” HACCP plans, we noted that units of measurement for temperatures listed were not always included. For example, your “Smoked Product & Ready Eat Product” and “Pasteurized/Fresh Crab Meat” HACCP plans list a critical limit of, (b)(4) at the Refrigerated Storage CCP. The unit of measurement is not confirmed to be Fahrenheit as listed on other portions of these HACCP plans.  Your HACCP plans should consistently note a unit of measurement in all places where temperature, or any other type of measurement with associated units, is noted.
 
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.
 
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.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.  If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
                                                                                               
Please send your reply to the Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contactScott R. Izykat 518-453-2314 x1012 or scott.izyk@fda.hhs.gov. 
 
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1

Page Last Updated: 09/04/2017
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