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WARNING LETTER

K & S Food Center LLC MARCS-CMS 542484 — Dec 08, 2017

K & S Food Center LLC - 542484 - 12/08/2017


Delivery Method:
UPS

Recipient:
Recipient Name
Mr. Dasrat Persaud
K & S Food Center LLC

1420 Park Street

Hartford, CT 06106
United States

Issuing Office:
New York District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations East
Division 1
 

 
 

WARNING LETTER
CMS # 542484

VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

December 8, 2017

Mr. Dasrat Persaud, Co-Owner/President
Ms. Kamlapattie Persaud, Co-Owner
K & S Food Center, LLC
1420 Park Street
Hartford, CT 06106

Dear Mr. and Ms. Persaud:

The United States Food and Drug Administration (FDA) inspected your warehouse and distribution facility, located at 1420 Park Street, Hartford, CT, 06106 between October 17th, 2017 and October 24th, 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).

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 refrigerated, Back-Split Salted Mackerel-VP is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 are 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). You must also implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not follow the monitoring, record keeping and verification procedures included in your HACCP plan as follows:

a.) You are not following your monitoring procedure of “(b)(4)” using a “(b)(4)” for “(b)(4)” at the receiving critical control point (CCP) in your “Salted Mackerel/(b)(4)” HACCP Plan for your refrigerated, Back-Split Salted Mackerel-VP product to control the food safety hazards of pathogen growth, scombrotoxin (histamine) formation and Clostridium botulinum toxin formation, due to time/temperature abuse. From 11/1/2016 to 10/19/2017, your firm received this product on (b)(4) occasions but your firm only conducted receipt monitoring activities on 11/5/2016. You did 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 frequency of the Cooler temperature with “(b)(4)” at the Storage CCP in your “Salted Mackerel/(b)(4)” HACCP Plan for your refrigerated, Back-Split Salted Mackerel-VP product to control the food safety hazards of pathogen growth, scombrotoxin (histamine) formation and Clostridium botulinum toxin formation, due to time/temperature abuse. You did not monitor or have records to show (b)(4) of your continuous temperature monitoring device were being performed.

c.) You are not performing the verification procedures as listed in your “Salted Mackerel/(b)(4)” HACCP Plan at the Receiving CCP. You did not document the results of your verification procedure of “(b)(4)”. You did not provide calibration records or daily calibration checks of the continuous temperature recording device used to measure the temperature of the refrigerated, Back-Split Salted Mackerel-VP upon receipt at your firm.

d.) You are not performing the verification procedures as listed in your “Salted Mackerel/(b)(4)” HACCP Plan at the Storage CCP. You did not document the results of your verification procedure of “(b)(4)”. This data logger is used for the continuous monitoring of the temperature in Cooler #1, which was observed during the recent inspection of your firm, to contain refrigerated, Back-Split Salted Mackerel-VP. Additionally, you were unable to provide verification records documenting your (b)(4) calibration of the data logger, the (b)(4) review of your monitoring records and (b)(4) review of your corrective actions.

2.    To comply with 21 CFR 123.10, you must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who may otherwise be qualified through job experience to perform the record review required by 21 CFR 123.8(a)(3). Specifically, while your firm does have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing, that individual is not performing the record review involving critical control point monitoring, the taking of corrective actions and the calibration of process control instruments used in critical control point monitoring.

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, the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR Part 110) 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 the FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, (21 USC 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 non-compliance 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 USC 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 non-compliance 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: W. Martin Rennells, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact W. Martin Rennells at 518-453-2314 x1038 or william.rennells@fda.hhs.gov.
 

Sincerely,
/S/

Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1