- Family Loompya Corporation
- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
21 April, 2015 WL # 18-15
Alen N. Enriquez, C.E.O.
Family Loompya Corporation
2626 Southport Way, Suite F
National City, California 91950
Dear Mr. Enriquez:
We inspected your seafood processing facility, located at 2626 Southport Way, National City, CA, from January 13 – 14, 2015. 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 110 (21 CFR 123 & 110). 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 Vegetable and Shrimp Lumpia product is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
Additionally, based on our label review we find that your LUMPIA Savory Vegetables and Shrimp in a Thin Crispy Wrapper and LUMPIA Savory Vegetables in a Thin Crispy Wrapper products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. 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 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for Vegetable and Shrimp Lumpia (referred to as Shrimp Lumpia in the HACCP plan) does not list the food safety hazards of undeclared shrimp, wheat, and soy allergens. Furthermore, your HACCP plan lacks controls to ensure the subject allergens are properly declared on labeling, and to ensure that the correct label is applied to the product.
Your response does not address the failure to identify the shrimp, wheat and soy allergens, and include controls for the allergens in your HACCP plan. For additional guidance on HACCP controls for allergens please see the FDA Fish and Fishery Products, Hazards and Controls Guidance, Fourth Edition, Chapter 19.
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(s) “(b)(4)” at critical control point (CCP) #3 Receiving, to control undeclared sulfites listed in your HACCP plan for Vegetable and Shrimp Lumpia (Shrimp Lumpia). Specifically, in 2014 your firm received multiple deliveries of shrimp including the following:
You only have one supplier letter of guarantee that shrimp provided are sulfite free, from (b)(4), dated 03/11/2014; the letter is not specific to any particular lot or shipment. You do not have letters of guarantee from your suppliers for the above listed deliveries and you do not have any records of sulfite analysis from a third party laboratory, as required by your HACCP plan.
We have reviewed your response and find it is not adequate. Your response refers to an attached certificate of guarantee from (b)(4) Vietnam stating that all of their “Shrimp Raw PD IQF” supplied to (b)(4) in 2014 are sulfite free. Your letter further states that (b)(4) supplied your supplier with all of the shrimp you received in 2014. We were unable to find the subject certificate of guarantee attached to your response. In addition, invoices collected during the inspection from (b)(4), your supplier, show that you also received shrimp from Thailand (invoices #098367, 132335, 163590) and Guatemala (invoices #888603, 996686). Your letter also states you have demanded a letter of guarantee that shrimp are sulfite free for every future shipment and you will reject shipments without one. We will verify your implementation of the promised correction for future shipments during the next inspection of your facility.
1. Your LUMPIA Savory Vegetables and Shrimp in a Thin Crispy Wrapper and LUMPIA Savory Vegetables in a Thin Crispy Wrapper products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Specifically, the labels declare the serving size as “2 Pieces (85g)”; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for Mixed Dishes: Not measurable with cup, e.g., egg rolls, is 140g (add 55 g for products with gravy or sauce topping). The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
We have the following comments:
- If you choose to use a Contains statement in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the statement must declare all major food allergens intentionally added to the product. Your LUMPIA Savory Vegetables and Shrimp in a Thin Crispy Wrapper product label includes the statement “Allergy Statement: This product contains wheat and soy” as a separate statement on the product label. The statement is currently neither below nor adjacent to the ingredient information. It appears below the Nutrition information. As such, this statement could be viewed as a general label statement or an incorrect Contains statement and may potentially be confusing to consumers.
- We note that the LUMPIA products come with sweet and sour sauce packets; however, the serving size information and Nutrition Facts labels are not consistent with 21 CFR 101.9(b)(2)(i)(H) and 101.9(h)(1). Furthermore, since the packages contain egg rolls and sweet and sour sauce, it is unclear if the 15oz (425g) net weight declared on the principal display panels refer to the net weight of the egg rolls alone, or the net weight of the egg rolls and the sauce. We suggest that the net weight statement clearly delineate the weight of the egg rolls and the weight of the sauce so that consumers are fully informed as to the contents of the package.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
Foods: 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 one or more inspections 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 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
CAPT Dan Cline, Acting Director
Los Angeles District
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
Alonza E. Cruse, Director
Los Angeles District
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413