Inspections, Compliance, Enforcement, and Criminal Investigations
Hong Chang Corporation 10/21/2010
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Los Angeles District
RETURN RECEIPT REQUESTED
October 21, 2010
Ms. Hai Hua Li, President
Hong Chang Corporation, dba California Food International
10155 Painter Avenue
Santa Fe Springs, CA 90670-3017
Dear Ms. Li:
The Food and Drug Administration (FDA) conducted an inspection of your food storage and processing facility located at 10155 Painter Avenue, Santa Fe Springs, CA from July 7 - 23, 2010. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that food stored at your facility is 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)] because these food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
The following significant violations were observed during the inspection:
1) You failed to take effective measures to exclude pests from your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
The conditions observed include the following:
• Rodent excreta pellets in the storage refrigerator at your facility;
• Rodent excreta pellets in your Compressor Pump Room, in Storage Room (b)(4) your Repacking/Packing Room, and on food processing equipment;
• Contaminated bags of Perilla Seeds in the storage refrigerator at your facility with rodent excreta pellets and rodent urine on the bags and evidence of rodent guawing on bags of these food products stored in the refrigerator;
• Rodent excreta pellets and urine on bags of Soy Bean products, boxes of Dried Radish Stem products, (b)(4) Bread Crumb products, bagged (b)(4) Rice products and bagged Green Pea products;
• Evidence of rodent gnawing on bagged (b)(4) Rice products, bagged Black Bean products, bagged Perilla Seed products, bagged Brown Rice Flour products, bagged Red Whole Chili products, and bagged Brown Rice Flour products;
• Rodent traps on a bag of (b)(4) Rice products and on a box containing Roasted Black Sesame Seed products;
• Bird feces on an outer box containing Perilla Seed products;
• Rodent excreta pellets on bagged Chili Powder products, on boxes of Dried Kelp products, Gagocha Powder products, bags of Perilla Seed products, bags of Mixed Rice products, Red Whole Chili products, bagged (b)(4) Rice products, bagged (b)(4) Rice products, bagged Evaporated Food Grade Salt products, boxes of Natural Sea Salt products, boxes of Tempura Mix Powder products, boxes of Cabbage Kimchi products, bags of Radish Leaf products, bags of Soy Bean products, and bagged Brown Rice Flour products;
• Moth-like insects on bagged (b)(4) Rice products, and on bagged Soy Bean products;
• Rodent urine on boxes of Natural Sea Salt products; and
• A gap of approximately 1/2 inch at the base of an exterior door to your film's facility serving as an entryway for rodents and pests.
We acknowledge that on July 9, 2010, your firm voluntarily destroyed 36,814 lbs. of food products, including the above referenced adulterated food products. We note that not all the food products in the facility were destroyed, and' harborage areas still exist under pallets of food products not removed, as well as elsewhere in the facility. In your response, dated August 4, 2010, you state that your firm hired a new pest control company to correct the rodent infestation at your facility, hired one full-time janitor to inspect the facility on a daily basis and to be responsible for "routine housekeeping," and made structural repairs to an exterior door. You provide photographs that demonstrate cleaning was performed in your warehouse, and show an exterior door without any visible gap.
However, cleaning the facility and hiring a new pest control company may not be sufficient to eradicate pests living in walls, under pallets of remaining food products, in mechanical areas, such as within refrigeration units, in areas above suspended ceiling systems, and other areas within your facility. Further, the documentation submitted does not indicate the specific steps taken to repair the above referenced gap in the exterior door. You should provide additional documentation of the steps taken to exclude pests from your facility.
2) Your firm failed to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1).
The inspection disclosed that Freezer (b)(4) lacks adequate space for sanitation inspections. There are stacked pallets of frozen products with no space in between the pallets for performing inspections.
In your response, dated August 4, 2010, you state that your firm emptied and re-organized Freezer #(b)(4) in a manner that now provides aisle space, allowing free movement and the ability to inspect the space. However, we are unable to determine from your response the adequacy and the extent to which this corrective action has been carried out to provide sufficient space for the maintenance of sanitary operations within the freezer area. You should provide additional documentation of your corrective action and steps taken to prevent recurrence.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
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 noted violations and to prevent recurrence. Include documentation of the corrective action, including those you have taken since your August 4, 2010 response. 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 completed.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Dr. William Vitale, Compliance Officer at 949-608-2919.
Alonza E. Cruse