• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Calco Sprouts, Inc. 17-Oct-07

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

Public Health Service
Food and Drug Administration

 

Minneapolis District office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142


October 17, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 08-01

Gino Yang
President
Calco Sprouts, Inc.
2751 Minnehaha Avenue South
Minneapolis, Minnesota 55406-1546

Dear Mr. Yang:

We inspected your sprout processing facility located at 2751 Minnehaha Avenue South, Minneapolis, Minnesota, on May 10, 11, 15 and 31, 2007. As a result of that inspection we have found that your mung beans are adulterated within the meaning of sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 342(a)(1) and (4)] (the Act). In addition, after review of your labels, we have some labeling comments.

We collected and analyzed samples of your mung bean sprouts. Based on our analyses, your mung bean sprouts are adulterated within the meaning of section 402(a)(1) of the Act (21 U.S.C. § 342(a)(1)] in that they bear and contain a poisonous or deleterious substance, namely Listeria monocytogenes, (L. monocytogenes) which may render them injurious to health.

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. Foods that have been implicated in outbreaks of invasive listeriosis have been foods, such as sprouts, that are ready-to-eat. Therefore, the presence of L. monocytogenes in foods such as spouts represents a significant danger to public health.

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 even 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) of the Act, 21 U.S.C. § 3424a)(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 that may lead to the contamination of your product with L. monocytogenes were documented:

  • Evidence of rodents throughout the facility.

  • An employee was observed going into the restroom with gloved hands and returning to the production line with the same gloves without subsequently washing the gloves or sanitizing them.

  • The interior surface of the PVC pipe used to supply water to the sprout tank was patched with plastic wrap.

  • The sprout tanks contained old product residue which supports the growth of L. monocytogenes and may contaminate subsequent batches.

  • Seeds are sprouted over a period of 5-6 days at temperatures that support the growth of pathogens including L. monocytogenes.


We also recommend that you identify and eliminate the source(s) of contamination of L. monocytogenes. In order to accomplish this, it will be necessary to conduct environmental monitoring and test for the presence of L. monocytogenes or Listeria spp. and employ strict in-plant sanitation measures to prevent the proliferation of the organism in the plant.

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, the Current Good Manufacturing Practice regulation (21 CFR Part 110) and the labeling regulation (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all 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.

In addition to the charges above, we note the following comments regarding your product labels.

  • We note that the information panel on your Alfalfa Sprouts (4 oz.) product. label contains the claim "Good Source of Vitamins." However, according to your Nutrition Facts panel, your product meets the requirements for a"good source" claim for only one vitamin. A "good source" claim is defined under 21 CFR 101.54(c) as containing 10 to 19 percent of the Reference Daily Intake (RDI) or the Daily Reference Value (DRV) per reference amount customarily consumed (RACC). The RDI for vitamins is set out in 21 CFR 101.9(c)(8)(B)(4). The RACC for your product is 85g (see 21 CFR 101.12), which is also the serving size on your Nutrition Facts panel. However, according to the product label, your product only meets the "good source" requirements for vitamin C(10% of the RDI) because the only other vitamin declared is vitamin A with just 2% of the RDI.

  • For your information, we note that your Alfalfa Sprouts (2 lb.) product label declares "Good Source of Vitamin A" on its Principal Display Panel. As noted in the previous Comment, your product must contain 10 to 19 percent of the RDI of vitamin A per RACC in order to state this claim {21 CFR 101.54(c)].

  • Your Bean Sprouts (16 oz.), [redacted] (8 oz.), and Alfalfa Sprouts (4 oz.) products all contain nutrition information on their labels, but fail to declare trans fat in their Nutrition Facts panels. Regulations setting out when the declaration of Trans fat is required on the Nutrition Facts panel went into effect on January 1, 2006 {see., 21 CFR 101.9(c) (2)(ii); 68 FR 41433]. You should review all of your product labels to ensure they comply with these regulations. For additional information on trans fat labeling, go to http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat.

  • We note that your [redacted] (8 oz.) product, which you told our investigator is contract manufactured and labeled for a customer in [redacted], declares the place of business of the manufacturer, packer, or distributor on the label as [redacted]. Under the requirements of 21 CFR 101.5, the street address, city, State and ZIP code of the manufacturer, packer, or distributor must be declared on the label of your product; however, if the street address is shown in a current city or telephone directory, the street address may be omitted [see 21 CFR 101.5(d)]. The label declaration does not a ear resent the business address for Calco Sprouts or for the [redacted], customer.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation, such as verification records and revised labeling, 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.

Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.


Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

TSW/ccl