Inspections, Compliance, Enforcement, and Criminal Investigations
Sing Kung Corporation 02/23/2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Los Angeles District
Irvine, CA 92612-2606
RETURN RECEIPT REQUESTED
February 23, 2009
Louis (nmi) Choi
Sing Kung Corporation
12061 Clark Street
Arcadia, CA 91006-5829
Dear Mr. Choi:
The Food and Drug Administration (FDA) conducted an inspection of your acidified food manufacturing facility, located at 12061 Clark St., Arcadia, CA, from October 7th to October 15th, 2008. The inspection revealed that you manufacture an acidified food product, Madras Curry Paste, 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 Madras Curry Paste product in a plastic jar is considered to be an acidified food because the predominant ingredient in this product is a low-acid ingredient (reconstituted curry powder) that is acidified by the addition of vinegar to the product. During the inspection, our investigator documented deviations from the Act and the above-mentioned regulations related to the processing of your Madras Curry Paste product packed in 8-ounce plastic jars that cause this acidified food product to be adulterated under section 402(a)(4) of the Act.
The significant deviations are as follows:
1. Your firm failed to register, within 10 days after engaging in the manufacture, processing, or packing of acidified foods, information with FDA including the name of the establishment, principal place of business, and the location of each establishment in which that processing is carried on, as required by 21 CFR 108.25(c)(1). Specifically, your firm has been manufacturing Madras Curry Paste at your current location since 2002 but has not registered with the FDA as an acidified food manufacturer.
2. 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 Madras Curry Paste product. Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Process Filing for all Processing Methods Except Low-Acid Aseptic).
3. Your firm failed to prepare and maintain files on a current procedure for use for products under your firm's control, which your firm would ask the distributor to follow, including plans for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; for determining, the effectiveness of recalls; for notifying FDA of any recalls; and for implementing recall programs, as required by 21 CFR 108.25(e). Specifically, your firm has no written recall plan or procedure on file for your Madras Curry Paste, which is necessary to ensure a quick and adequate response in the event of a health hazard associated with this product.
During the inspection of November 2006, you were provided with the FDA Guide to Inspections of Acidified Food Manufacturers, FDA Instructions for Establishment Registration & Filing, including Establishment Registration Form 2541, and Industry Guide for Electronic Filing of Acidified & Low Acid Food Processors. Use these informational guides to assist you in complying with the acidified food regulations.
You can find the Act and the acidified food regulations through links in FDA's home page at http://www.fda.gov. More information on registration and filing 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.cfsan.fda.gov/~comm/lacf-s1.html. 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:
John L. Stevens
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 Robert B. McNab, Compliance Officer, at (949) 608-4409.
Alonza E. Cruse
Los Angeles District
Cc: California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413