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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shanghai Co Inc 7/6/09

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021·4421
Telephone: 425·486·8788
FAX: 425-483-4996


July 6, 2009

 

 

VIA FEDEX

In reply refer to Warning Letter SEA 09-22


David J. Louie, President
Shanghai Company, Inc.
2510 S.E. 28th Street
Portland, Oregon 97202

WARNING LETTER

Dear Mr. Louie:

We inspected your bean sprout processing facility, located at 2800 S.E. Division Street, Portland, Oregon, on February 19 and 20, 2009.

We collected sample number 487936, consisting of nine finished nine ounce packages of Mung bean sprouts, during this inspection and received the laboratory analyses on March 16, 2009. Based on the results of the analysis of your packaged finished product, your packaged Mung bean spouts were contaminated with the pathogen Listeria monocytogenes rendering them adulterated within the meaning of Section 402(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 342(a)(1)], in that your Mung bean sprouts contain a poisonous or deleterious substance which may render them injurious to health.

We also collected sample number 513141, consisting of 36 environmental swabs. The results of the analysis of these environmental swabs also found the pathogen Listeria monocytogenes in your facility. Based on the results of the laboratory analysis of the environmental swabs collected during the inspection and the objectionable conditions observed during the inspection, you are operating your processing facility in a manner which renders your Mung bean sprout products adulterated within the meaning of Section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or been rendered injurious to health.

A report of the analytical results of samples 513141 and 487936 was mailed to you by our Pacific Regional Laboratory-Northwest on March 16,2009.

You may find the Act and the Current Good Manufacturing Practice regulation for human food through links in FDA's home page at www.fda.gov.

Listeria monocytogenes (L. monocytogenes) is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility. L. monocytogenes can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to Listeriosis. In the past, sprouts that are ready-to-eat (RTE) have been implicated in outbreaks of invasive listeriosis.

L. monocytogenes can be isolated from soil, silage and other environmental sources and can also be found in man-made environments such as food processing establishments. Any moist area, such as your sprout production area, can harbor L. monocytogenes. This organism can grow at refrigeration temperatures. During our inspection, we documented conditions and practices that may lead to the contamination of your products with pathogens such as L. monocytogenes and may be conducive to pathogen growth in your products. As such, the products manufactured in that facility are adulterated within the meaning of Section 402(a)(4) the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

The following conditions were noted during the current inspection of your facility:

1. Persons working in direct contact with food failed conform to hygienic practices to the extent necessary to protect against contamination of food. Specifically, employees handling food failed to wash hands thoroughly and sanitize them after handling unclean objects. This was evidenced by:

a. A production worker, who was wearing latex gloves, picking up a ladder in the bean sprout growing room with gloved hands and then moving in-process bean sprouts out of the growing bin without first washing or sanitizing his gloved hands; and
b. A production worker, who was wearing latex gloves, touching the processing room floor with gloved hands and then using the gloved hands to touch finished product without first washing or sanitizing his gloved hands.

2. Your firm failed to adequately clean food-contact surfaces as frequently as necessary and to handle tools in a manner appropriate to protect against contamination of food, as evidenced by the following:

a. Dirt and dried product residues on the food contact surface of the elevated lift-conveyor that carries product to the bagging machine;
b. A shovel, which was used to transfer ice from an ice machine to a wash tank that contained in-process Mung bean sprouts, being stored directly on the floor of the processing room and on the top of the ice machine, where accumulated dust and dirt was observed. The shovel was not washed or sanitized prior to use;
c. Dried residue and Mung bean sprout pieces on interior wall of the flume that carries the sprouts from the growing rooms to the processing room;
d. A dark residue, appearing to be mold, on the interior surface of the pipe supplying water to the flume that carries the sprouts from the growing rooms to the packaging room.
e. Two aprons and two sets of gloves were observed stored against a soiled wall. Employees, who were packaging finished products, used these aprons and gloves without first washing and sanitizing them.

3. Your firm failed to take effective measures to protect food from contamination while being transported by conveyor (i.e. your water flume). Specifically, condensate was observed dripping into the flume from the overhead area of a cut-through in a wall while the flume was carrying Mung bean sprouts from the growing rooms to the packaging room.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

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 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 reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.

 

Sincerely,

 

/s/

 

Charles M.Breen
District Director



Enclosure:
Copy of FDA 483
cc: ODA, with disclosure statement

 

 

***

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell. WA 98021-4421
Telephone: 425·486·8788
FAX: 425·483-4996


July 6,2009

VIAFEDEX

In reply refer to Warning Letter SEA 09-22

David J. Louie, President
Shanghai Company, Inc.
2510 S.E. 28th Street
Portland, Oregon 97202

Dear Mr. Louie:

FDA has modified the warning letter sent to your firm on July 1, 2009. The modified letter is enclosed and replaces the previous letter sent on July 1. If you have any questions regarding this letter, please contact Mr. Michael J. Donovan at (425) 483-4906.

Sincerely,

 

/s/


Charles M. Breen
District Director


Enclosure:


Modified Shanghai Warning Letter