| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 |
Department of Health and Human Services
August 10, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-21
Hugo F. Chang, Owner
Farm and Wild Fresh Paradise Gourmet Foods
425 SE 3rd Avenue, B-3
Portland, Oregon 97214
WARNING LETTER
Dear Mr. Chang:
On April 13, 15, and 20, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your produce repacking operation located at 425 SE 3rd Avenue, Portland, Oregon. During the inspection, the FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, part 110 (21 CFR part 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on the Internet through links on FDA’s web page at www.fda.gov.
Your significant violations are as follows:
1. As required by 21 CFR 110.37(a), running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. However, you have failed to provide running water for cleaning of equipment, utensils and food-packaging materials, and employee sanitary facilities. Specifically, there is no running water in the firm for hand-washing and cleaning and sanitizing of equipment. The closest water source is located upstairs in the building’s community restroom.
2. As required by 21 CFR 110.10(b), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to, washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated (21 CFR 110.10(b)(3)). However, you failed to wash and sanitize hands thoroughly in an adequate hand-washing facility at any time your hands may have become soiled or contaminated. Specifically, you wiped your nose with a tissue and scratched your head, and then subsequently returned to handle products without washing your hands. In addition, you must take any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with micro-organisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin (21 CFR 110.10(b)(9)). However, you failed to take necessary precautions to protect against contamination of food, food contact surfaces, and food packaging systems with microorganisms and foreign substances. Specifically, you had a bandage on a finger on your left hand while you were cutting fresh chives and repacking mushrooms with your bare hands. The bandage is a bacteria harborage area and is not susceptible to cleaning or sanitizing.
3. As required by 21 CFR 110.35(d)(5), sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment. However, you failed to use a procedure for cleaning and sanitizing of utensils that has been shown to provide adequate cleaning and sanitizing treatment. Specifically, you explained to the investigators that only water is used to clean the processing table and processing utensils. The processing utensils include scissors and a knife. The processing utensils are rinsed with water in a bathroom sink located one floor above the processing area. After rinsing, the utensils are dried with a paper towel. The processing table is sprayed with water using a spray bottle and wiped with a towel. The spray bottle is filled only with water. Soap and sanitizer are not used in the cleaning process.
4. As required by 21 CFR 110.80(b)(5), work-in-process shall be handled in a manner that protects against contamination. However, you failed to handle work-in-progress in a manner that protects against contamination. Specifically, you culled the chives by manually knocking bunches of chives on the interior of a rubbish bin. When the bunches of chives were knocked on the interior of the rubbish bin, dead and smaller chive pieces would fall from the bunch into the rubbish bin. The rubbish bin was used for refuse from throughout the facility and the interior of the rubbish bin had build-up of dirt. The remaining chives would be immediately packaged for distribution.
5. As required by 21 CFR 110.40(a), all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. However, you failed to use equipment made from materials that allow for proper cleaning and maintenance. Specifically, you used newspapers as a food contact surface for cutting and holding fresh chives during processing. Additionally, newspapers were used to cover produce in the walk-in cooler. Newspapers are not a material that can be effectively cleaned and sanitized, therefore they may harbor bacteria and should not be used as a food contact substance.
6. As required by 21 CFR 110.20(b)(1), the plant and facilities shall provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. However, you failed to store your materials in such a manner that allowed for sufficient maintenance of sanitary operations and the production of safe food. Specifically, there were boxes, crates and other miscellaneous items stored near the processing area, which create pest harborage areas and prevent the monitoring of pest activities.
The above is not intended to be an all-inclusive list of violations. You are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action such as seizure and/or injunction without further notice.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4426. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at 425-483-4926.
Sincerely yours,
/S/
Charles M. Breen
District Director
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