WARNING LETTER
Grupo VPAS C.A.
MARCS-CMS 682516 —
October 17, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Antonio J. Strocchi
Recipient Title
President
Grupo VPAS C.A.
Urb. Los Ruices Sur, Trieste Local Galpon S/N
Caracas
1071
,
Miranda
Venezuela
aj.strocchia@vpasgrupo.com
e.galicia@vpasgrupo.com
Issuing Office:
Human Foods Program
United States
WARNING LETTER
Reference # 682516
Dear Mr. Antonio J. Strocchi:
The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, Grupo VPAS C.A., located at Urb. Los Ruices Sur, Trieste Local Galpon S/N, Caracas, Miranda, 1071, Venezuela, on January 22 - 26, 2024. During the remote assessment, 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). At the conclusion of the assessment, the FDA investigator discussed items of concern. We acknowledge receipt of your response via email on February 16, 2024, which included a revised HACCP plan for fresh-frozen, IQF Medregal fillet with skin and without skin dated February 2024, and other documents all written in Spanish. We requested a translated copy in English on April 22, 2024; however, no response was received to this date. Therefore, we used Google Hub Translate, a trustworthy tool, to translate the documents you submitted in your February 16, 2024 response. Our evaluation is based on our review this translation.
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 HACCP plan for fresh-frozen, IQF Medregal fillet with skin and without skin 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 June 22 4th Edition of the
Fish and Fisheries Products Hazards and 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 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.” As a primary processor, you should monitor internal temperatures of the fish at vessel offloading and from the offloading site to your processing facility by truck which requires controls for transportation conditions (i.e., ambient temperature). However, your HACCP plan for fresh-frozen, IQF Medregal fillet with skin and without skin dated February 2024, does not list critical control points for vessel offloading and transportation conditions, specifically:
a. Vessel offloading requires that internal temperatures are monitored during offloading from the vessels to assess the adequacy of handling aboard the harvest vessels.
b. Transportation conditions from the vessel offloading site to the processing facility to prevent (scombrotoxin) histamine formation. Internal temperatures alone are inadequate if products are transported longer than
(b)(4)
. Transportation conditions, such as the adequacy of ice or ice slurry surrounding the fish or refrigeration temperature maintained below
(b)(4)
°C with a continuous recorder, should be monitored during transport and evaluated upon delivery to the processing facility to ensure amberjack has not been exposed to unsafe temperatures.
2. You must have a HACCP plan for your fresh-frozen, IQF Medregal fillet with skin and without skin that at 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 “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, the critical limits listed at the
(b)(4)
step PCC1 and the
(b)(4)
step PCC2 of your HACCP plan are inadequate to control the hazard of histamine. Specifically,
a. The critical limit of “
(b)(4)
” is inadequate to control the hazard of histamine formation. Although you indicate you are checking each incoming fish, when the presence of decomposition meets or exceeds 2.5% odors of decomposition within the vessel lot, it indicates that unsafe handling conditions may have occurred aboard the vessel and that histamine formation may have occurred which require corrective actions. The plan should establish a critical limit of less than 2.5% for the presence of persistent odors of decomposition.
b. The critical limit of “
(b)(4)
” is adequate for a single fish. The process description describes that no less than 18 individual fish will be tested in each harvest lot consistent with FDA’s safety recommendations; however, the monitoring procedures in your HACCP plan do not list the minimum number of fish to be tested and is inadequate in its absence.
c. The critical limit “
(b)(4)
” is inadequate to control histamine formation at the
(b)(4)
step PCC2. Adequate critical limits for storage address the actual holding conditions for the fish, such as ice surrounding the fish or cooler temperatures maintained below
(b)(4)
°C and monitored with a continuous temperature monitoring device. Monitoring the internal temperature of the fish does not provide the necessary assurance that the entire fish is sufficiently chilled to prevent histamine formation.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan at the receiving
(b)(4)
step PCC1, to comply with 21 CFR 123.6(b) and (c)(4). Specifically,
a. Your firm told our investigator that you do not implement the monitoring procedures/frequencies at the reception of
(b)(4)
CCP1 for controlling the hazard of Ciguatera toxin, to comply with 21 CFR 123.6(b). Your HACCP plan requires to follow the procedures described in a document titled “
(b)(4)
.“ However, the monitoring records provided to FDA do not document that you are confirming that each lot received has been authorized by
(b)(4)
.
b. The listed monitoring frequency “
(b)(4)
” for “
(b)(4)
” is inadequate as described above. Our investigator reported that all fish are examined organoleptically. Your HACCP plan does not list this information as a monitoring frequency for the critical limit. A minimum of 118 fish or the entire lot of fish if less than 118 fish are received should be examined.
c. Based on your Process Description (Section 11.1) a minimum of 12 fish are monitored for internal temperature between 0°C and 4.4°C, at “discharge”; this does not reflect in your HACCP plan. The record “PCC1: Control de Peligros Fisico-Quimicos Y Microbiologicos En La Reception” includes temperatures, pH, chlorine, and decomposition observations. The monitoring record shows only a single temperature observation which supports that the plan is inadequate.
For additional guidance you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 4th Edition at https://www.fda.gov/media/80637/download, Chapter 7 Scombrotoxin (histamine) Formation; and Chapter 19 Undeclared Major Food Allergens and Certain Food Intolerance Substances.
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 (with English translations), 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
In addition to the above, we also offer the following comments:
Although your HACCP plan does not identify the hazard of allergens, the amberjack fillet label declares the allergen. Your HACCP plan should include Labelling as a critical control point to control the possible hazard of allergens (fish). All fish are considered major food allergens by FDA and must be addressed in your HACCP plan. Your HACCP plan should identify critical control points which ensure that product labels received and applied accurately declare the presence of allergens.
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 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.
You should direct your written reply to Giselle Jordan, Human Foods Program, Office of Compliance & Enforcement/Office of Enforcement/Division of Produce & Imports/Imports Enforcement Branch, located at 5001 Campus Drive, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Giselle Jordan via email at Giselle.jordan@fda.hhs.gov. Pease reference CMS #682516 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Amy Barringer
Acting Director
Office of Enforcement
Office of Compliance & Enforcement
Human Foods Program
Content current as of:
11/26/2024
Regulated Product(s)
Food & Beverages