Inspections, Compliance, Enforcement, and Criminal Investigations

Marfish, Inc. 3/6/14

  

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
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-05
March 6, 2014
Nestor J. Romeo
President and Owner
Marfish, Inc.
1375 NW 89th Ct., Suite #2
Doral, Florida 33172
 
Cc: Alejandro Etayo, Secretary and Owner
 
Dear Mr. Romeo:
 
We inspected your seafood processing facility, located at 1375 NW 89th Ct. Bay#1, Suite #2, Miami, Florida 33172 on December 17th and 18th, 2013. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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). Accordingly, your fresh aquacultured Sea Bass and refrigerated canned Pasteurized Crabmeat 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 and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
Your significant violations were as follows:
 
1.    You must implement the monitoring procedures and frequency that 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 procedures for your canned pasteurized crabmeat at the receiving and refrigerated critical control point to control pathogen growth and Clostridium botulinum toxin formation, due to time/temperature abuse. Specifically,
 
a)      Your firm does not have records for monitoring the receiving CCP and verifying the CCP for canned pasteurized crabmeat as mentioned in your HACCP Plan for this product. The last receiving entry record for canned pasteurized crabmeat was on July 18, 2013, and it was reviewed on July 30, 2013. This is a repeat observation listed as Observation #1b in the form FDA 483, Inspectional Observations, dated May 08, 2008.
 
b)      You do not keep a written record of the results of the ice checks at the Storage in Cooler CCP as a verification procedure for canned pasteurized crabmeat. The last complete record for the ice check was documented on May 29, 2013, and the last record review was performed on April 27, 2013. This is a repeat observation listed as Observation #1c in the form FDA 483, Inspectional Observations, dated May 08, 2008.
 
c)      You did not provide calibration records or daily calibration checks of the thermometer(s) used to measure the temperature of the canned pasteurized crabmeat upon receipt at the firm, to ensure the product’s temperature is at 40°F or below per the Receiving Critical Limit CCP since July 06, 2012.
 
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, to comply with 21 CFR 123.11(b). However, your firm did not monitor safety of water; maintenance of hand-washing, hand-sanitizing and toilet facilities; condition and cleanliness of food contact surfaces; labeling, storage and use of toxic compounds; and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:
 
a.    The drainage pipe from the hand-washing sink in the processing room is separated from the floor drain and drains waste water directly onto the floor between the 3-compartment sink and the fish repackaging table.
 
b.    There is no hot water in the processing room 3-compartment sink and in the hand washing sink. This is a repeat observation listed as Item #2020, in the FDA-State Contract Inspection dated October 15, 2010.
 
c.    An unlabeled bottle of sanitizer between the 3-compartment sink and the hand washing sink adjacent to the fish repackaging table. This is a repeat observation listed as Item #41, in the FDA-State Contract Inspection dated October 15, 2010.
 
d.    Condensation on the walls, ceiling, and floor in the cooler and freezer. Frozen condensate was observed on a box of Sea Bass product. This is a repeat observation listed as Item #37, in the FDA-State Contract Inspection dated October 15, 2010.
 
e.    The outside garbage dumpster was full and the lid was not closed. This is a repeat observation listed as Item #33, in the FDA-State Contract Inspection dated October 15, 2010.
 
3.    You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand-washing, hand-sanitizing and toilet facilities, protection from adulterants, labeling, storage and use of toxic compounds, and exclusion of pests required for the processing of refrigerated canned pasteurized crabmeat from July 23, 2012, and sanitation correction records for safety of water, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand-washing, hand-sanitizing and toilet facilities, protection from adulterants, labeling, storage and use of toxic compounds, and exclusion of pests as evidenced by:
 
a.    You do not keep sanitation control records to document key points of sanitation. The last sanitation monitoring was documented on July 23, 2012. This is a repeat observation listed as Observation #2, in the form FDA 483, Inspectional Observations, dated March 27, 2007, as observation #6, in the form FDA 483 dated May 8, 2008, and as Item #2020, in the FDA-State Contract Inspection dated October 15, 2010.
 
4.    Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for canned pasteurized crab meat at the Storage in Cooler critical control point to control pathogen growth and Clostridium botulinum toxin formation as a result of time and temperature abuse is not appropriate.  It is incomplete because your corrective action of “readjust temperature in cooler” and “re-ice” does not address the root cause of a critical limit deviation nor the holding, segregation, and/or final disposition of the affected product.
 
5.    You failed to sign your HACCP plan, as required by 21 CFR 123.6(d). Our Investigator observed your firm’s HACCP plans for canned pasteurized crab meat, fresh bass, salmon, and hake were not signed by appropriate personnel at least annually and were last signed on June 12, 2008.
 
Although you promised a written response at the close of the inspection to address the form FDA 483, Inspectional Observations, we have not yet received your written response.
 
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
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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.
 
Please send your reply to the Food and Drug Administration, Attention: Randall L. Morris, Compliance Officer at 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Randall L. Morris at 407-475-4741.
 
                                                                       
Sincerely,
/S/
Kathleen M. Sinninger
Acting Director, Florida District

Page Last Updated: 03/27/2014
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