Inspections, Compliance, Enforcement, and Criminal Investigations
Niitikaya USA Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Los Angeles District
RETURN RECEIPT REQUESTED
June 17, 2009
Mr. Victor K. Suda
Executive Vice President
Niitikaya USA Inc.
1801 Gage Road
Montebello, CA 90640-6505
Dear Mr. Suda:
We inspected your food processing facility, located at 1801 Gage Road, Montebello, California 90640, on January 6-7, 2009.
The inspection revealed that you manufacture an acidified food product and ready-to-eat vegetable products. In addition, you import ready-to-eat seafood at your facility.
As a manufacturer of acidified food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be
required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filling of process information, and the mandatory requirements in 21 CFR Part 114. In addition, based on certain criteria in Part 114, acidified foods may be adulterated within the meaning of Section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be located through FDA's homepage at http://www.fda.gov (http://www.cfsan.fda.gov/~comm/lacf-toc.html).
During the inspection, the FDA investigator documented deviations from the Act and the above identified regulations relating to the processing of your sliced ginger product that cause this acidified food product to be adulterated under section 402(a)(4) of the Act in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
Your significant violations of the acidified food regulations are as follows:
1. Your firm failed to provide the FDA, not later than 60 days after registration, and before packing any new product, information on the scheduled processes, including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and
source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, at the time of the inspection, you had failed to file a scheduled process for the acidified food sliced ginger.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic) as required by 21 CFR 108.25(c)(2). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available through links on FDA's website at www.fda.gov.
Your February 25, 2009, response to the 483 does not adequately address this violation. Although your response states that you are preparing processes for your sliced ginger product, as of the date of this letter, FDA has not received a scheduled process for this
2. Your firm failed to register with the FDA information including the name of the establishment, principal place of business, and the location of each establishment in which that processing is carried on, within 10 days after engaging in the manufacture, processing, or packing of acidified foods, as required by 21 CFR 108.25(c)(1). Specifically, your firm produces an acidified food, sliced ginger, but has not registered with the FDA as an acidified food manufacturer.
Your February 25, 2009, response to the 483 does not adequately address this violation. Although your response indicates that you are in the process of registering, as of the date of this letter, your firm has not registered as an acidified food manufacturer with the FDA.
We also 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. 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, the ready-to-eat dried fish and seafood products that you process in your facility are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. 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 of the Seafood HACCP regulations are as follows:
1. Your firm failed to 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). Specifically, your firm did not maintain sanitation monitoring records for monitoring:
• 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, including utensils, gloves, and outer garments;
• prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces;
• 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 compounds;
• Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces;
• and exclusion of pests required for the processing of the ready to eat seafood products dried bonito, salted ice fish, and pickled sardines.
Your February 25, 2009, response to the 483 does not adequately address this violation. Your response indicates that you are maintaining daily sanitation control records; however, because you have not provided details regarding the content of these records, it is unclear
whether these records document the monitoring and corrections set out in 21 CFR 123.11(b) and thus comply with 21 CFR 123.l1(c).
2. Your firm failed to implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). Specifically, the affirmative step performed by your firm is not adequate to meet this requirement. You obtained a document titled "Products Safety Certificate" from (b)(4) for various products manufactured by that firm in (b)(4) This certificate you provided states that temperature control is managed and only certifies that the imported "products are safety." Under 21 CFR 123.l2(a)(2)(ii)(B), an affirmative step may include obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of the HACCP regulation. This certificate does not certify that the implied fish or fishery products were processed in accordance with 21 CFR Part 123.
Your February 25, 2009, response to the 483 does not adequately address this violation. Your response indicates that you have requested written verification procedures from the (b)(4)" However, this response does not indicate that you have obtained a certificate that meets the requirements of 21 CFR 123.12(a)(2)(ii)(B) or that you have taken alternative affirmative steps under 21 CFR 123.12(a)(2)(ii).
We also found that you have significant deviations from the current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods manufactured at your facility to be 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
Your significant sanitation violations include:
1. Your firm failed to conduct all food manufacturing, including packaging and storage, under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2).
a. On numerous occasions, visibly soiled hoses that had been lying on the wet processing room floor came in direct contact with in-process foods and food processing water. Our investigator observed a hose submerged in a soak tank at the end of the ginger tumble washer, a hose submerged in cucumber wash water in an agitating washer, and a hose submerged in a tank of water that was used to rinse cabbage processing equipment and utensils.
b. Colanders of peeled Daikon radish and chopped cabbage were placed directly on the wet processing room floor during production. Neither of these foods are subjected to further rinsing prior to packing.
c. The nozzle on a hose was in direct contact with the wet processing room floor. An employee picked the soiled hose up off of the floor, handled the soiled nozzle to initiate water flow, and used the same soiled hand to spread flowing water from the nozzle tip onto cucumbers at the end of the agitating cucumber washer. The cucumbers do not receive an additional rinse prior to cutting and packing.
d. Ready-To-Eat (RTE) cut salad came in direct contact with soiled strip curtains at a door to your cooler as a colander of the cut salad sitting on top of a pail was slid through the strip curtains.
e. An employee using a hose to rinse processing equipment and the processing room floor caused water to splash from the floor and the soiled equipment directly onto exposed RTE cabbage.
2. Employees working in direct contact with food did not wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility at any time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically:
a. All of your food processing employees perform the following sequence of actions immediately prior to resuming processing after each break: 1.) Hair nets and aprons are put on. 2.) The employees wash their hands. 3.) The employees handle soiled processing boots while removing them from a storage rack and putting them on. 4.) The employees handle soiled sandals while placing them on the storage rack. 5.) The employees enter the processing room through a set of soiled strip curtains and resume production without further hand washing.
b. An employee opening wood crates of cabbage dropped a wood slat onto the wet processing room floor. The employee picked the wood slat up off of the floor and discarded it, and then the employee proceeded to handle the cabbage while halving the cabbage heads and feeding them into the cabbage chopper; the employee did not wash his hands after handling the soiled wood slat.
c. An employee handled a soiled hose that had been on the wet processing room floor while rinsing cabbage processing equipment and the floor, and then the employee proceeded to handle RTE cabbage without first washing his hands.
Your February 25, 2009, response to the 483 does not adequately address these violations. Your response indicates that you will replace the water hoses with overhang pre-rinse units; however, it is unclear how you will prevent these units from also coming in contact with the
processing room floor. You also indicate that you will train employees to follow "correct" and "proper" handling methods, but it is unclear from this response whether such training will be sufficient to prevent the violations listed under items 1 and 2 above from recurring.
3. Your firm failed to store raw materials under conditions that protect against contamination and minimize deterioration, as required by 21 CFR 110.80(a)(1). Specifically, you store the raw ingredient fermented ginger root in your exterior parking lot; the ginger root is packed in
plastic-bag lined wood-slat crates. The crates of ginger root are stored unprotected against contamination from pests, wind-borne filth, and rain. Evidence of pest activity observed on the ginger crates includes rodent feces and wood-boring insect detritus. Many of the ginger
crates exhibited evidence of leakage in the form of stained crate slats and salt deposits on the exterior of the crates, and the tops of the plastic bag liners in many of the crates were visibly soiled.
Your February 25, 2009, response to the 483 does not adequately address these violations. Your response indicates that you will buy covers for the crates used to store your ginger in the exterior parking lot and that you are arranging to store raw ingredients in another warehouse. However, you do not describe these covers or the conditions under which the raw ginger will be stored in another warehouse; therefore, it is unclear whether these measures will be sufficient to protect the ginger from contamination.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. Other violations can subject the food 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. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
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 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.
Please send your written response to:
Acting Director of Compliance
U.S. Food and Drug Administration
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Ms. Datoc at (949) 608-4428.
Alonza E. Cruse
Cc: Jeff Farrar, DVM, PhD, MPH
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413