WARNING LETTER
Chean Industries Dominicana S.R.L.
MARCS-CMS 660107 —
July 10, 2023
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Daniel C. Chean
Recipient Title
General Manager/Co-Owner
Chean Industries Dominicana S.R.L.
19911 58th Ave., 1 FL
Flushing
,
NY
11365
United States
dchean@gmail.com
el.siscador258@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
July 10, 2023
WARNING LETTER
Reference #660107
Dear Mr. Daniel C. Chean:
The United States Food and Drug Administration (FDA) conducted a foreign inspection of your seafood processing facility, Chean Industries Dominicana S.R.L., located at Calle 21 No. 3, De La Urbanización Los Girasoles Del Este, Santiago, Dominican Republic (the) 51000 on February 28 - March 01, 2023. During the inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection.
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 dried sea cucumbers products 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 Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Your significant deviations are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). Specifically, your firm does not have a HACCP plan for dried sea cucumbers to control the food safety hazards of environmental chemicals, and pathogenic bacterial growth and toxin formation due to time/temperature abuse, specifically
Staphylococcus aureus (S. aureus)
.
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 21 CFR 123.3(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 “
(b)(4)
” step for dried sea cucumbers conducted at a temperature range of
(b)(4)
°C –
(b)(4)
°C for
(b)(4)
days is not adequate to control pathogenic bacteria growth and toxin formation. Specifically, the critical limits (time and temperature parameters) do not ensure that the maximum finished product water activity (Aw) is 0.85 or below to control the food safety hazard of
Staphylococcus aureus (S. aureus)
.
(b)(4)
the product sufficiently to reduce the water activity to 0.85 or below is critical to obtaining a safe final product. This value is based on the minimum water activity for toxin formation of S. aureus. Achieving the above-mentioned water activity will also inhibit the growth of other microbiological hazards. FDA recommends that your firm establish the
(b)(4)
parameters utilizing a scientific validation study to ensure that the final product will consistently achieve a water activity of 0.85 or below. Once all the parameters are validated, the critical factors for achieving the established water activity of less than 0.85 should be included as Critical Limits in the HACCP plan.
For additional guidance you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 Edition at https://www.fda.gov/media/80637/download, Chapter 9 for Environmental Chemical Contaminants Including Pesticides and Chapter 12 Pathogenic Bacterial Growth and Toxin Formation (Other Than
Clostridium botulinum
) as a Result of Time and Temperature Abuse.
3. You must maintain adequate 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 control records that document monitoring and corrections of sanitation deficiencies for the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests. Specifically, on March 1st, 2023, the investigator requested sanitation monitoring records and your firm only had a calendar of weekly cleaning with boxes to check off the general area that was cleaned (kitchen,
(b)(4)
room, patio) and the initials of the person that did the cleaning. Sanitation monitoring records must document the monitoring and corrections for each of the eight key sanitation control procedure items listed above.
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 deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your HACCP plan for dried sea cucumbers, 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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
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. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.html.
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, including the seafood HACCP regulation (21 CFR Part 123) and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (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: Giselle Jordan, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #660107 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/18/2023
Regulated Product(s)
Food & Beverages