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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Santos Incorporated 8/15/12

  

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

Public Health Service
Food and Drug Administration
 

San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-6700

WARNING LETTER

VIA UPS

August 15, 2012

Purnima A. Parmar, President
Santos Incorporated
1188 Montague Street
San Leandro, California 94577

Dear Mrs. Parmar:

The Food and Drug Administration (FDA) conducted an inspection of your facility located at 1188 Montague Street, San Leandro, California, between March 8 and March 23, 2012.  During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 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 the FDA regulations through links in FDA's homepage at www.fda.gov

In addition, labels for several of your products were collected.  We have reviewed your labels and find that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).

Current Good Manufacturing Practice

1. As required by 21 CFR 110.80(b)(1), you must maintain all equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary.  In addition, as required by 21 CFR 110.35(d), you must clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against the contamination of food.  However, our investigator observed the following during the inspection:

• Throughout the inspection, none of the equipment (metal vats, wooden tables, metal scoops, metal surfaced scales, metal sifters, and heat shrink wrap machines) used in the repacking operation were observed properly cleaned or sanitized. Between repacking of one food product to another, employees were seen wiping equipment and utensils with various dirty rags seen used repeatedly to wipe down the same equipment and utensils.

• All-purpose flour was observed being packaged, followed by the work surface being wiped down by an employee; however, after the surfaces were wiped down, residue from the all-purpose flour was still observed being present on the working surfaces.

• Employees were seen repackaging in sequence, raw peanuts, cardamom, cumin-jeera (whole), mustard seed, and garam masala. Each time a product had been processed, employees were seen using the same two rags to wipe down the repacking equipment. Raw peanut residue was observed remaining inside the metal vat and on the metal sifter after being wiped down by the employee. The employee then used the same metal vat and metal sifter to process cumin-jeera. No adequate cleaning or sanitizing was observed.

• Approximately 10 rags were seen being used to wipe down equipment and utensils used in three repacking stations. According to your firm, the rags are cleaned daily by an employee who takes them home for washing. Throughout the inspection, these rags were seen stained and dirty with debris from repackaged food products, and were stored in a manner which did not protect them from contamination such as, draped on a dirty fan and on a garbage receptacle.

2. As required by 21 CFR 110.10(b)(3), all persons working in direct contact with food, food contact surfaces, and food-packaging materials must wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable organisms) in an adequate hand-washing facility at any time when the hands may have become soiled or contaminated. In addition, they must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food.  This includes maintaining gloves used in food handling in an intact, clean, and sanitary condition, as required by 21 CFR 110.10(b)(5). However, our investigator observed the following during our inspection:

• Employees were observed starting work without washing their hands at the start of repackaging and after returning to work.

• Employees were seen wearing gloves while packing down garbage, tuning a radio, handling a cell phone, sweeping chick peas off the floor, and touching cardboard boxes, wooden pallets, and the floor. Each time the employees were seen returning to repackage food products without washing their hands or changing their gloves.

3. As required by 21 CFR 110.40(a), equipment and utensils shall be so designed as to be adequately cleanable, and shall be properly maintained. Additionally, per 21 CFR 110.40(c), equipment that is in the food handling area that does not come into contact with food shall be so constructed that it can be kept in a clean condition. However, our investigator observed the following during our inspection:

• Work surfaces used to support repacking equipment and utensils, such as scoops, packaging materials, scales, and heat sealers, were observed constructed of cardboard boxes and wood. These materials cannot be adequately cleaned and sanitized. The porous nature of these materials was observed to harbor debris from previously packaged products, such as all purpose flour, corn flour, turmeric, and chili powder.

4. As required by 21 CFR 110.37(e)(1), you are required to provide adequate hand-washing facilities at each location in the plant where needed. However, our investigator observed that there is no hand washing facility in close proximity to the repackaging area. In order to wash their hands, employees must open and close two doors to access the restroom on the opposite side of the building where there is a hand washing receptacle.

Labeling 

Your All Purpose Flour (Maida) product is misbranded within the meaning of section 403(w) [21 U.S.C. § 343(w)] in that the label fails to declare the presence of the major food allergen, wheat, as required by section 403(w)(1).

Section 201(qq) of the Act  [21 U.S.C. 321(qq)] defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:

• The word “Contains”, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. 343(w)(1)(A)], or

• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “spelt (wheat)”, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source (e.g. “wheat gluten” or “whole wheat flour”) or the name of the food source appears elsewhere in the ingredients list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. 343(w)(1)(B)].

Your 5 lb All Purpose Flour (Maida) product is misbranded within the meaning of section 403(b) [21 U.S.C. § 343(b)] in that your firm repackages the product from bulk containers labeled as “Enriched Flour” into 5 lb bags and offered for sale under the name, “All Purpose Flour,” which is the name of a different food.

Your All Purpose Flour (Maida) product is misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, the ingredient statement for the (b)(4) Enriched Flour, which you repack and relabel as All Purpose Flour, declares the sub-ingredients “wheat flour, benzoyl peroxide, niacin, reduced iron, ascorbic acid, thiamine mononitrate, riboflavin, amylase, folic acid”; however, you fail to declare these ingredients on your finished product label.

Your retail packaged, All Purpose Flour (Maida), Macaroni and Peas Besan products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the products fail to bear a nutrition facts panel as required by 21 CFR 101.9.

Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemption in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/SmallBusinessNutritionLabelingExemption/default.htm] for information on filing for an annual exemption. The application may be submitted online at: https://info1.cfsan.fda.gov/nle/client/login.cfm.

We acknowledge that your firm voluntarily recalled food products due to potential allergen cross contamination on May 18, 2012. In addition, you have stated verbally that you intend to correct the GMP deficiencies per the 483 Observations; however to date we have not received a written response regarding any proposed corrective actions.

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.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrective action you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections.  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 written response should be directed to:

Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052

Refer to the Unique Identification Number (CMS case 303819) when replying.

If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.

This letter is 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.  The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance.  Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.

Sincerely,

/s/

Barbara J. Cassens
District Director