Inspections, Compliance, Enforcement, and Criminal Investigations
Golden Pacific Foods Inc. 7/29/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2606
RETURN RECEIPT REQUESTED
July 29, 2010
Ricky T. Lee, President/CEO
Golden Pacific Foods, Inc.
13895 Magnolia Avenue
Chino, CA 91710-7028
Dear Mr. Lee:
We inspected your seafood processing and importer establishment, located at 13895 Magnolia Avenue, Chino, California on April 1-2, 2010. 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 and 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).
Accordingly, your Shrimp Chips are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, we found your products to be misbranded under 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, CGMP regulations for food, and labeling regulations for foods on FDA's home page at www.fda.gov.
Based on your inspection and your FDA 483 response dated 4/15/2010, 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 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). However your firm does not have a HACCP plan for shrimp chips (various flavors), which are made with real shrimp meat, to control the food safety hazards of pathogen survival through cooking, undeclared food intolerance substances such as sulfites, and undeclared allergen ingredients such as milk, eggs, or soy.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Pact 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor: 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 with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
On 04/01/10 the following sanitation deficiencies were observed at your facility:
a. A hose approximately 30 feet in length was observed to be connected to a sink faucet in your shrimp chip cooking area and the faucet was observed to lack a back flow prevention device.
b. Prior to the start of operations there were food residues on the food contact surfaces of the post-frying chip tumbler, on the metal staples and belt of the conveyor belt from the chip tumbler to a hopper, on the cupped steps of the chip elevator to the weighing hopper, and on the weighing hopper.
c. Tape was observed on the food contact surface of the hopper that feeds the shrimp chip elevator and on the hopper feeding the shrimp chip bagging machine.
d. The section of the chip bagging machine that comes into contact with the interior of the shrimp chip bags as they formed was visibly soiled.
e. Food residue was observed in rough welds on the food contact surfaces of the chip tumbler and the post-tumbler chip hopper prior to the start of processing.
f. Soiled cardboard was on the top of the chip fryer, and foil was taped onto the chip hopper before the chip elevator.
g. Webbing was observed hanging from the ceiling directly above the exposed food contact surfaces, the chip elevator and weighing hopper.
h. Two visibly soiled fans where used to cool cooked shrimp chips.
i. The sole production area hand washing sink was visibly soiled, and no warm water was available at this hand washing sink.
j. There was one unlabeled chemical spray bottle in the shrimp chip processing room.
k. An employee working at the shrimp chip packing station was observed to be wiping his sniffling nose with his hands throughout the production of shrimp chips. This employee did not wash his hands at any time during processing, including after at least three occasions of wiping his nose with his bare hands.
l. An employee was observed eating while packing ready to eat shrimp chips and beverages were observed in the processing room.
m. Approximately five rodent excreta pellets were observed on top of the water heater next to the shrimp chip fryer. In addition, spiders and webbing were observed throughout the facility.
n. There is insufficient space between pallets of raw ingredients and pallets of finished product to allow for adequate sanitation monitoring of your storage area.
3. 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 does not maintain any sanitation monitoring records for any of the eight key sanitation conditions and practices required for the processing of ready-to-eat shrimp chips (various flavors) on days that you process these chips (at least once a week).
4. You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the US FDA seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, you performed affirmative steps that were not adequate as follows:
i. The copy of the foreign processor's HACCP plan you maintain on file for shrimp crackers (b)(4) manufactured by (b)(4) does not identify the potential food safety hazards of undeclared allergens, such as eggs and milk, and food intolerance substances, such as sulfites.
ii. The copy of the foreign processor's HACCP plan you maintain on file for shrimp cracker pellets, manufactured by (b)(4) does not identify the potential hazards of undeclared allergens, such as eggs, and food intolerance substances, such as sulfites.
iii. If you choose to maintain a copy of the foreign processor's HACCP plan on file as an affirmative step, to comply with 21 CFR 123.12(a)(2)(ii) (D), you must also maintain a copy, in English, of a written guarantee from the foreign processor that the imported fish and fishery product is processed in accordance with the FDA seafood HACCP regulation. However, you failed to maintain copies of written guarantees from (b)(4)
iv. The lot-by-lot certificates you obtained from (b)(4) for shrimp crackers (b)(4) manufactured by (b)(4) and shrimp cracker pellets, manufactured by (b)(4) do not provide certify that the imported fishery products were processed in accordance with the US FDA seafood HACCP regulation. If you choose to obtain either a continuous or a lot-by-lot certificate from an appropriate foreign government inspection authority, or competent third party, to comply with 21 CFR 123.12(a)(2)(ii) (B),the certificates must certify compliance with the US FDA seafood HACCP regulation, 21 CFR 123.
We acknowledge and appreciate your firm's response dated April 15, 2010. A review of this response, however does not find that you have adequately addressed any of the items in the letter. Your response is written in very general terms and promise corrective actions both immediately, within weeks and also in unspecified timelines. In addition, your response did not include verification of any corrections you have made in response to the observations listed above, such as copies of your HACCP plans, monitoring documents, work orders for equipment corrections, etc.
In addition, your Bar-B-Que, Onion & Garlic and Sour Cream & Onion Flavored Shrimp Snacks products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the major food allergens, milk and soy as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refilled oils, as "major food allergens." A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• The word "Contains" followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredient, section 403(w)(1)(A) of the Act, [21 U.S.C. 343(w)(1)(A)], or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. (wheat)"), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, [21 U.S.C. 343(w)(1)(B)].
Milk: The formulation sheet for the "Shrimp Crackers (b)(4) a sub-ingredient of your Shrimp Snacks, declares sweet condensed milk as an ingredient. However, the labels on the finished Shrimp Snacks products fail to declare the presence of the major food allergen, milk.
Soy: The ingredient statements for the Onion & Garlic Snack Seasoning and BBQ Shrimp Seasoning, used in the manufacture of your Shrimp Snacks products, declare hydrolyzed soy protein as an ingredient. The ingredient statement on your Bar-B-Que and Onion & Garlic Flavored Shrimp Snacks declare "Hydrolyzed Vegetable Protein" but fails to specifically declare it as Hydrolyzed Soy Protein.
Your Bar-B-Que, Onion & Garlic and Sour Cream & Onion Flavored Shrimp Snacks products are also misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight. Specifically, the formulation sheet for the "Shrimp Crackers (b)(4) declares sweet condensed milk and baking powder as sub-ingredients but your product fails to list both ingredients on the finished product labels.
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
We acknowledge your response during your inspection to voluntarily recall these three flavors of shrimp chips from retail markets and consumers on April 1, 2010.
We may take further action if you do not promptly collect these violations. 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," seize your product(s) and/or enjoin your film from further violating the Act.
We may take further action if you do not promptly correct these violations. 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," seize your product(s) and/or enjoin your firm from further violating the Act.
You should respond in writing within 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 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 608-4409. Your written reply should be addressed to:
Blake Bevill, Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612
Alonza E. Cruse, Director
Los Angeles District