Inspections, Compliance, Enforcement, and Criminal Investigations
Myojo USA, Inc. 10/13/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
October 13, 2009
Mr. Takuro Okada, CEO/President
Myojo USA, Inc.
6220 Prescott Ct
Chino, CA 91710-7111
Dear Mr. Okada:
The Food and Drug Administration (FDA) conducted an inspection of your acidified food manufacturing facility, located at 6220 Prescott Ct Chino, CA, from May 28, to June 1, 2009 and August 13, 2009. The inspection revealed that you manufacture an acidified food product, Udon Japanese Style Noodles, at your facility.
As a manufacturer of an acidified food product, 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 filing of process information, and the mandatory requirements in 21 CFR Part 114. In addition, based upon 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 have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food and Emergency Permit Control regulations through links on the FDA's home page at: http://www.fda.gov.
Acidified foods are low-acid foods to which acid or acid foods are added. They have a water activity greater than 0.85 and a finished equilibrium pH of 4.6 or below (21 CFR 114.3(b)). Your Udon Japanese Style Noodles which are stored at ambient temperature are considered to be an acidified food because the predominant ingredient in this product is a low-acid ingredient (flour based dough) that is acidified by the addition of lactic acid to the product.
We acknowledge receipt of your response dated June 11, 2009 in which you provided photos of corrections made at your facility as a result of the May 28 to June 1, 2009 inspection. The agency has reviewed Myojo U.S.A.'s letter identified above and although some of the items that were discussed during the close out of the inspection appear to have been corrected, we continue to have the following concerns.
During the inspection, our investigator documented deviations from the Act and the above-mentioned regulations related to the processing of your Udon Japanese Style Noodles that cause this acidified food product to be adulterated under section 402(a)(4) of the Act.
The significant deviation is as follows:
1. Your firm failed to provide, not later than 60 days after registration and before packing any new product, the FDA with 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, your firm has not filed information on the scheduled processes for your acidified Udon noodle products. Scheduled process information for acidified foods must be submitted on Form FDA 2541a (process Filing for all Processing Methods except Low-Acid Aseptic).
We received your letter on October 7, 2009 with the attached FDA form 2541a for Udon Noodles along with process documents in Japanese. Process filing forms and supporting documents must be provided in English and submitted to the LACF Registration Coordinator, Center for Food Safety and Applied Nutrition (FDA), 5100 Paint Branch Parkway, College Park, MD 20740-3835. The requirements and instructions for filing a process can be found online in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://www.fda.gov/Food/FoodSafetv/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/Instructions/ucm2007436.htm You can also find the Act and the acidified food regulations through links in FDA's home page at http://www.fda.gov.
Additionally, we have the following comments based on observations made during the inspection:
It is not clear, based on your film's method of monitoring and recording steam sterilization temperature and time for the Udon noodles, whether the product achieves your process parameters (b)(4). Specifically, it is difficult to determine the actual time and temperature reading on the temperature recorder chart since the smallest interval is (b)(4) minutes for time and (b)(4) temperature. In addition, it is not clear from reviewing the steam sterilization record, whether the Udon process parameters were achieved. For example, the steam sterilization record dated 5-28-09 for Lot#(b)(4) show that the product was not (b)(4):
• Rack#(b)(4) and (b)(4) shows a "TEMP. REACH/TIME" as"(b)(4)"and TIME OUT" as"(b)(4)" and the temperatures recorded for the "(b)(4)" "(b)(4)", and "(b)(4)"marks were (b)(4) and (b)(4).
• The run for rack#(b)(4) and (b)(4) indicates "(b)(4)" for the TEMP. REACH time and "(b)(4)" for the TIME OUT. This record shows a process time of (b)(4).
You indicated that you would be adjusting the chart recorder to increase the time scale and would be revising the steam sterilization record from.
Furthermore, we note that if sodium benzoate is used as a chemical preservative in your products, then it must be declared on your labels by common or usual name (ie., sodium benzoate) along with a description of its function (e.g., "preservative," "to retard spoilage," "a mold inhibitor") as specified under 21 CFR 101.220). We note that a copy of your Hime Nama-Udon Oriental Style Noodles product labels was collected as part of the May-June 2009 inspection and sodium benzoate was not declared on the label. On August 13, 2009, during an update inspection, a copy of your Hime Nama-Udon Oriental Style Noodles product label was collected and "sodium benzoate" was declared, however, the function was not specified.
These as well as other issues discussed in this letter will be followed up during the next scheduled inspection.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Act and FDA regulations, including the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulations (21 CFR Part 110). You should take prompt action to correct any deviations, including those identified in this letter. Failure to promptly correct these deviations may result in regulatory actions without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to ensure that similar violations will not recur. Include in your response any documentation showing the corrective actions taken or proposed to be taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.
Your written reply should be sent to:
Acting Director, Compliance Branch
FDA - Los Angeles District Office
Irvine, CA 92612
If you have any questions regarding the content of this letter, please contact Marco Esteves, Compliance Officer, at (949) 608-4439.
Alonza E. Cruse
Los Angeles District