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  5. Min Jiang Food Store, Inc., dba Koi Koi Trading - 583758 - 08/02/2019
  1. Warning Letters

WARNING LETTER

Min Jiang Food Store, Inc., dba Koi Koi Trading MARCS-CMS 583758 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. RenFen Qui
Recipient Title
President
Min Jiang Food Store, Inc., dba Koi Koi Trading

1146 S. Vail Ave
Montebello, CA 90640
United States

Issuing Office:
Office of Human and Animal Food Division 5 West

United States

WARNING LETTER

UNITED PARCEL SERVICE
SIGNATURE REQUIRED

August 02, 2019

WL # 583758

Mr. RenFen Qui, President
Min Jiang Food Store, Inc., dba Koi Koi Trading
1146 S. Vail Ave
Montebello, CA 90640

Dear Mr. RenFen Qui:

We inspected your seafood processing facility, located at 1146 S. Vail Ave, Montebello, CA on April 23 and 26, 2019.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 117 (21 CFR 123 & 117). 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 filleted salmon for raw consumption and refrigerated vacuumed packaged surimi seafood 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 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 conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan entitled “HACCP plan for Fresh Filleting Non Scrombroid Fish Products – (Raw Consumption)” does not list a critical control point for controlling the food safety hazard of parasites. This HACCP plan includes ready-to-eat salmon that your firm receives, stores, and distributes under refrigeration. We note that your hazard analysis indicates parasites are reasonably likely to occur; however, your HACCP plan does not include a critical control points, such as freezing.

Please refer to Chapter 5 (Parasites) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for guidance in determining the appropriate controls for your processing operations.

2. 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 procedure of “continuous monitoring with (b)(4)” at the “Cooler Storage (Raw Material and finished product)” (CCP #2) and Cooler Storage (finished product) #4 critical control points to control pathogen growth and toxin formation listed in your HACCP plan entitled “HACCP plan for Fresh Filleting Non Scrombroid Fish Products – (Raw Consumption).” Specifically, during the inspection you told the investigator that the employee responsible for monitoring the cooler did not have access to the electronic database used to record the cooler temperatures and therefore could not monitor the continuous temperature critical limit.

In addition, your firm did not follow the monitoring procedure of “continuous monitoring with (b)(4) and (b)(4)” at the “Finished Product Storage” critical control point (CCP #2) to control Clostridium botulinumtoxin formation listed in your HACCP plan entitled “HACCP plan Refrigerated Vacuumed Packed Smoked Fish and Ready to Eat products.” As stated above, during the inspection you told the investigator that the employee responsible for monitoring the finished product cooler did not have access to the electronic database used to record the cooler temperatures and therefore could not monitor the continuous temperature critical limit.

Lastly, during our inspection you stated that you routinely process seafood products on (b)(4); however, HACCP monitoring activities are only conducted (b)(4). You are required to implement monitoring procedures whenever your firm processes ready-to-eat and vacuum-packaged seafood.

3. You must 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 record monitoring observations at the receiving critical control point (CCP #1) to control pathogen growth and toxin formation listed in your HACCP plan entitled “HACCP plan for Fresh Filleting Non Scrombroid Fish Products – (Raw Consumption).” Specifically, you received fresh raw salmon from the following; (b)(4) on April 5, 9, 13, 15, 16, and 17, 2019; (b)(4) on April 9 & 13, 2019; and (b)(4) on April 9, 2019 but did not have receiving monitoring records for these shipments.

In addition, your firm did not record monitoring observations at the receiving critical control point (CCP #1) to control Clostridium botulinum listed in your HACCP plan entitled “HACCP plan Refrigerated Vacuumed Packed Smoked Fish and Ready to Eat products.” Specifically, you received refrigerated vacuum-packaged surimi on March 7 & 29, 2019, but did not have receiving monitoring records for these shipments.

Lastly, your HACCP plans entitled “HACCP plan for Fresh Filleting Non Scrombroid Fish Products – (Raw Consumption)” and “HACCP plan Refrigerated Vacuumed Packed Smoked Fish and Ready to Eat products” both have cooler storage critical control points that reference a “(b)(4) printout” record. However, during our inspection, your firm failed to have (b)(4) printout records.

4. 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 every day seafood processing is conducted and during (b)(4). Specifically, during our inspection, your firm stated that you routinely process fish on (b)(4), but sanitation monitoring is only conducted (b)(4). In addition, your firm did not monitor sanitation conditions during (b)(4).

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 117 Subpart B). 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:

Sergio Chavez, Director Compliance Branch
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502

If you have questions regarding any issues in this letter, please contact Tammy Hancock at 510-337-2922 ext 103.

Sincerely,
/S/

Darla R. Bracy, District Director
Office of Human and Animal Food
Division 5 West


cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capital Avenue – MS7602
P. O. Box 997413
Sacramento, California 95899-7435
 

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