Inspections, Compliance, Enforcement, and Criminal Investigations

Azuma Foods (Suzhou) Co., LTD. 1/30/18

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

WARNING LETTER

JAN 30, 2018

VIA EXPRESS DELIVERY

Norimitsu Suzuki, Trading Department
Azuma Foods (Suzhou) Co. Ltd.
No. 195 Putuoshan Road, SND
Suzhou, Jiangsu, China 215163

Reference # 544079
 

Dear Mr. Suzuki:

On November 9-10, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility Azuma Foods (Suzhou) Co. Ltd., located at No. 195 Putuoshan Road, Suzhou, Jiangsu, China. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA's issuance of an FDA 483, lnspectional Observations that lists the serious deviations found at your firm. We acknowledge receipt of your response sent via email on November 20, 2017. Your response included your revised HACCP plan entitled "Seasoned Capelin Roe With Soy Fiber" dated November 13, 2017; completed monitoring records; and photographs of cleaned overhead refrigeration unit. However, our evaluation of the documentation revealed that the response was not adequate, as further explained in this letter.

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 frozen ready-to-eat vacuum packaged seasoned capelin roe with soy fiber product is adulterated, in that it has been prepared, packed, or held under conditions whereby it 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 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 revised HACCP plan entitled "Seasoned Capelin Roe With Soy Fiber" provided with your response does not list critical control points or one combined critical control point for the unrefrigerated processing steps of rinsing, seasoning, and draining to control the hazard of pathogen growth. During our inspection, your firm indicated the (b)(4) steps take approximately (b)(4) hours at ambient temperatures (i.e., unrefrigerated). As such, FDA recommends you control the cumulative time exposure of your raw, ready-to-eat roe products during these unrefrigerated processing steps to control pathogen growth.

2.    You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21CFR123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard". However, your firm's revised HACCP plan entitled "Seasoned Capelin Roe With Soy Fiber" provided with your response lists a critical limit, "(b)(4)", at the "(b)(4)" critical control point that is not adequate to control the food safety hazard of pathogen growth. FDA recommends holding products at a cooler temperature of 4.4° C or below and not (b)(4)° C as listed in your plan. Additionally, during our inspection the investigator observed your cold storage temperature at (b)(4)° C. In addition, it appears your critical limit includes an error, in that (b)(4)° C is not equivalent to 32° F.

3.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21CFR123.6{c)(4). However, your firm's revised HACCP plan entitled "Seasoned Capelin Roe With Soy Fiber" provided with your response lists a monitoring procedure/frequency that is not adequate, specifically:

a.  The "(b)(4)" critical control point is not adequate to control pathogen growth. Your HACCP plan lists (b)(4). However, FDA recommends that when monitoring product temperatures during processing (i.e., thawing), firms should monitor surface temperature of the product using a temperature indicating device (e.g., a thermometer) at least every 2 hours. In addition, your revised HACCP plan references "(b)(4)" of the room temperature along with monitoring product temperatures at a critical limit of (b)(4)° F ((b)(4)° C). However, our investigator observed that your firm thaws the roe for approximately (b)(4)hours at room temperature (i.e., unrefrigerated at approximately (b)(4)° C). Please provide additional information regarding how your firm ensures that the products are maintained at or below your listed critical limit of (b)(4)° F ((b)(4)° C) during this (b)(4) step.
b.  The "(b)(4)" critical control point is not adequate to control pathogen growth. FDA recommends monitoring the ambient air temperature of the cooler using a continuous temperature-recording device (e.g., a recording thermometer) with a visual check of the device itself and of the recorded data at least once per day.

4.    Because you chose to include a corrective action plan in your HACCP plan, your described corrective action
must be appropriate, to comply with 21CFR123. 7{b). However, your corrective action plan for your
seasoned capelin roe with soy fiber is not appropriate, specifically:

a. At the "(b)(4)" critical control point, your corrective action plan does not ensure that no adulterated product enters commerce. In addition to re-labeling, FDA recommends segregating and returning or destroying any label stock or pre-labeled packaging stock that does not contain the proper statement and determining and correcting the cause of the improper labels.
b. At the "(b)(4)" critical control point, your corrective action plan does not correct the cause of the deviation. In addition to adjusting the cooler temperature and holding and evaluating the product based on time and temperature exposure, FDA recommends modifying the process as needed to reduce the time and temperature exposure. 

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

Additionally, 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 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 foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your U.S. Agent.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov. Please reference CMS# 544079 on any submissions and within the subject line of any emails to us.
 

Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition 

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