Inspections, Compliance, Enforcement, and Criminal Investigations
Caguas Bakery 05-Apr-04
Department of Health and Human Services
Public Health Service
San Juan District
April 15, 2004
RETURN RECEIPT REQUESTED
Mr. Cruz Torres Fonseca
Georgetti Street #3
Caguas, Puerto Rico 00725
Dear Mr. Torres Fonseca:
On November 18-20, 2003, the U.S. Food and Drug Administration (FDA) inspected your food manufacturing facility located at Georgetti Street #3, Caguas, Puerto Rico. The inspection revealed multiple recurrent violations of the Federal Food, Drug, and Cosmetic Act (the Act), and the requirements of Title 21, Code of Federal Regulations, Parts 101 (21 CFR 101-Food Labeling) and 110 (21 CFR 110-Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food). You can find the Act and CFR references through links on FDA's home page at www.fda.gov.
The following deviations make your products adulterated within the meaning of Section 402(a)(4) of the Act (21 USC 342(a)(4)), in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
1. You failed to take effective measures to exclude pests from the processing areas as required by 21 CFR 110.35(c). Our investigator observed at least five live flies over processing equipment, raw material, finished products and the floor.
2. You failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Our investigator observed that some of the screens in the manufacturing area were broken and other areas lacked screens.
3. You failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition and insufficient repair to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Our investigator observed dirty walls in the manufacturing area and water dripping through the ceiling to the inside of all areas of the establishment.
The following products were identified during Our most recent inspection to be in violation of the Act due to undeclared artificial color additives:
• Your "Galletas Cucas" and "Relleno" products are adulterated under Section 402(c) of the Act (21 USC 342(c)) because they contain FD&C Yellow No. 5, and the presence of that ingredient is not declared on the product labels. You must specifically declare the presence of FD&C Yellow No. 5 in the ingredient statement on your product labels to comply with 21 CFR 74.705(d)(2). The declaration of FD&C Yellow No. 5 as an ingredient is a condition for safe use of this color additive in food products.
• In addition, your "Galletas Cucas" and "Relleno" products are misbranded under Section 403(i)(2) of the Act (21 USC 343(i)(2)) because the labels fail to declare the presence of the certified color additives FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40. In accordance with 21 CFR 101.22(k)(1), certified color additives must be individually declared in the ingredient statement by their common or usual name. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No."(e.g., Yellow 5).
Violations involving undeclared color additives were brought to your attention during the past and current inspections. Our office also sent you correspondence dated February 4, 2003, advising you about the proper declaration of artificial color additives on food product labels. We also noted that from your affidavit signed on 11/20/04, your "Galletas Casco" product is not manufactured with any color additives, but is labeled as containing "Amarillo Vegetal."
Your "Galletas Cucas," "Galletas Casco," and "Relleno" products are misbranded under Section 403(e)(2) of the Act (21 USC 343(e)(2)) because the labels fail to declare the net quantity of contents as required by 21 CFR 101.105(a): The net quantity of contents statement for these products must be expressed in terms of net weight, declared in both avoirdupois pounds and ounces. The net quantity of contents statement may also be expressed as a combination of the net weight and numerical count [21 CFR 101.105(a)]. We noted that your labels declare "Contiene: 12-16-20 piezas" (i.e., "Contains: 12-16-20 pieces"), however, this statement is not an accurate statement of the numerical count because you do not indicate whether the package actually contains 12, 16, or 20 pieces.
Your "Galletas Cucas," "Galletas Casco," and "Relleno" products are further misbranded under Section 403(q)(1) of the Act (21 USC 343(q)(1)), because their labels fail to bear nutrition labeling as required by 21 CFR 101.9.
In addition, the investigator observed that enriched flour is used to manufacture the Galletas Cucas," "Galletas Casco," and "Relleno" products. Enriched flour is a multi-ingredient food that is subject to a standard of identity that is defined in 21 CFR 137.165. We noted that the ingredient statements on the referenced products identify the flour as "wheat flour" and do not list the vitamins and minerals that are required under the standard of identity for "enriched flour." The food labeling regulations at 21 CFR 101.4 establish the requirements for the designation of ingredients on a food label. For an ingredient that conforms to a standard of identity and that itself has two or more ingredients, such as enriched flour, the sub-ingredients of the ingredient must be identified in the ingredient statement, unless exempt [21 CFR 101.4(b)(2)]. This requirement may be met either by parenthetically listing the component ingredients after listing "enriched flour," or by listing the component ingredients without listing the common or usual name of the main ingredient. Under the first alternative, the component ingredient must be listed in descending order of predominance within the parenthesis (e.g., enriched flour (flour, thiamin, riboflavin, niacin, folic acid, iron)); and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
We may take action without further notice if you do not promptly correct these violations. For example, we may seize your products and/or enjoin your firm from operating. Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of specific steps you have taken to correct these violations, including an explanation of each step being taken to prevent the recurrence of the violations. If you cannot complete all corrections before you respond, we expect you will explain the reason for the delay and a deadline by which you will correct any remaining deficiencies.
The above identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. As a food manufacturer, it is your responsibility to ensure your products meet all the requirements of the Federal, Drug, and Cosmetic Act (FD&C Act), Code of Federal Regulations (CFR) and the regulations promulgated there under.
Your written reply should be addressed to the Food and Drug Administration, Attention: Miguel A. Hernandez, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901.
Donald J. Voeller
San Juan District