Inspections, Compliance, Enforcement, and Criminal Investigations
SR Rosati, Inc. 9/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
September 7, 2012
Richard M. Trotter, Owner
SR Rosati, Inc.
201 E. Madison A venue
Clifton Heights, PA 19018-2616
Dear Mr. Trotter:
The U.S. Food and Drug Administration (FDA) inspected your processing facility, located at 201 E. Madison Avenue, Clifton Heights, PA, on May 30, 2012 through June 6, 2012. Our inspection found significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for food manufacturers, Title 21, Code of Federal Regulations, (21 CFR), Part 110. These violations cause the foods distributed by your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, our inspection found significant deviations from the food labeling regulations, 21 CFR, Part 101. These violations cause the foods, distributed by your facility, to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], in that they are not labeled with the mandatory information required by the Act. You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Your significant cGMP violations are as follows:
1. Your plant is not constructed in such a manner as to prevent condensate from contaminating food [21 CFR 110.20(b)(4)]. Specifically, during the manufacturing of in-process water ice in your bulk room on May 30 and/or May 31, 2012, our investigator observed:
• Insulation covering pipes that had accumulated condensate and the surface area of the insulation appeared to be degrading in that pieces of it were missing. The batch freezers and open buckets containing in-process water ice were located directly below these pipes.
• Electrical insulation wire with dust particles directly over a (b)(4) uncovered hopper containing in-process water ice.
• A one-half inch piece of pipe material hanging from what appeared to be jagged edged extension pipe, which was directly over a (b)(4) uncovered hopper containing in-process water ice.
2. Your firm failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food [21 CFR 110.35(d)]. Specifically, on May 31, 2012, our investigator observed:
• Blackish/brownish residue on the underside rim of several (b)(4) green plastic buckets, containing in-process water ice, obtained from the batch freezers. The water ice product was observed being poured from the buckets, into a hopper which was to be pumped to the filling machine, to fill 6oz. containers of “Cry Berry Cherry” water ice.
• Three employees pouring the contents of buckets of in-process water ice into a hopper in the bulk room, and into another hopper in the filling room. The buckets had been staged on the floor and contained liquid and blackish/brownish material under the rim of the buckets.
• The floor of a dolly used to transfer buckets of in-process water ice to a hopper in the filling room had two eight inch by ten inch pitted areas, filled with an accumulation of red colored liquid.
• An employee used a spatula to stir in-process water ice and then placed the spatula on top of the adjacent batch freezer. The employee then used the same spatula in another bucket containing in-process product.
• An employee used a wooden handled spatula to remove excess in-process water ice from leaking out of the door of the batch freezer by wedging it between the batch freezer door and the front side of the batch freezer.
3. Your firm failed to provide hand washing facilities at each location in the plant where needed [21 CFR 110.37(e)(1)]. Specifically, our investigator observed that there are no hand washing stations in the bulk room and filling room. The fact that your firm failed to have adequate hand preparations for hand washing is of immense concern to FDA and we must stress the importance of this aspect of food safety.
4. Your employees failed to wash hand thoroughly in an adequate hand-washing facility before starting work to protect against the contamination of food [21 CFR 110.10(b)(3)]. Specifically;
• On May 30, 2012, two employees were observed loading in-process water ice onto a dolly and then grasped the handle of the dolly to move the product to the filling room. This process was repeated several times without the employees washing their hands.
• On May 31, 2012, an employee was observed rinsing his hands in a bucket and wiped his face and nose. The employee then proceeded to handle buckets that were lined up to be filled with in-process water ice from the batch freezers, without washing his hands.
• On May 30, 2012, two employees that were working in the bulk room, where water ice is manufactured, were observed by our investigator, proceeding to the warehouse to load packaging supplies on a dolly. As they walked to the warehouse they were seen touching the plastic curtain that separates the warehouse and filler room. The plastic curtain had numerous smudged prints and areas with dark and whitish material. The employees failed to remove their gloves or wash their hands upon returning to the filling area, where they unloaded the product packaging containers for the next day’s production.
5. Your employees failed to hair nets, and appropriate hair restraints in an effective manner to protect against the contamination of food [21 CFR 110.10(b)(6)]. Specifically, on May 30, 2012, during the production of in-process water ice, our investigator observed:
• Two employees wearing hair nets; however, the top portion of their hair was exposed when walking throughout the bulk room and filling room.
• Four employees wearing ball caps in lieu of hair restraints had their hair exposed. Two of these employees were handling containers with in-process water ice, another was stirring in-process product in a vat, and the other was pouring ingredients into a hopper
6. Your firm failed to provide devices and fixtures that are designed and constructed to protect against recontamination of clean, sanitized hands [21 CFR 110.37(e)(4)]. Specifically, our investigator observed an employee turn on the manual hot and cold water spigot handles at the hand washing station. The employee was also observed turning off the spigot with his clean hands.
7. Your firm failed to provide adequate screening or other protection against pests [21 CFR 110.20(b)(7)]. Specifically, on May 30, 2012, during the production of “Cry Baby Cherry” water ice, our investigator observed both garage warehouse doors open, with only plastic curtains separating the warehouse and the filling room. On May 30 and 31, 2012, our investigator observed three small flying insects in the bulk room and two small flying insects where water ice is manufactured.
Your significant labeling violations are as follows:
8. Your Passion Fruit Italian Water Ice (6 fl. oz.) and Cry Baby Sour Watermelon Water Ice (6 fl. oz.) products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive's listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your Passion Fruit Italian Water Ice and Cry Baby Sour Watermelon Water Ice products are manufactured with (b)(4) and (b)(4) respectively which contain FD&C Yellow No. 5; however, the labels for the finished products fail to declare the presence of FD&C Yellow No. 5 in the ingredient statements.
9. Your Passion Fruit Italian Water Ice (6 fl. oz.), Cry Baby Sour Watermelon Water Ice (6 fl. oz.), and Cry Baby Sour Apple Italian Ice (6 fl. oz.) products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that it is fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient. Specifically,
• Your Passion Fruit Italian Water Ice is made with (b)(4) which contains FD&C Yellow No. 5 and FD&C Blue No. 1; however your product label fails to declare these colors.
• Your Cry Baby Sour Watermelon Water Ice product is made with (b)(4) which contains FD&C Yellow No.5; however your product label fails to declare this color.
• Your Cry Baby Sour Apple Italian Ice product is made (b)(4) which contains FD&C Red No. 40; however your product label fails to declare this color.
According to 21 CFR 101.4(b)(1), the name of an ingredient shall be a specific name and not a collective (generic) name, except that spices, flavorings, colorings and chemical preservatives shall be declared according to the provisions of 101.22. A color additive or the lake of a color additive subject to certification under 721(c) of the act shall be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter, except that it is not necessary to include the "FD&C" prefix or the term "No." in the declaration, but the term "Lake" shall be included in the declaration of the lake of the certified color additive (e.g., Blue 1 Lake) [21 CFR 101.22(k)(2)].
According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or “sub-ingredients”) may be met by either (i) parenthetically listing the component ingredients after the common or usual name of the main ingredient, or (ii) by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. Also under the second alternative, every ingredient in a multi-component ingredient must be declared in the ingredient statement.
10. Your Passion Fruit Italian Water Ice (6 fl. oz.), Cry Baby Sour Watermelon Water Ice (6 fl. oz.), and Cry Baby Sour Apple Italian Ice (6 fl. oz.) product labels are misbranded within the meaning of section 403(a)(1) and 201(n) of the Act, 21 U.S.C. §§ 343(a)(1) and 321(n), in that the labels are false or misleading because they fail to reveal the material fact that the identified characterizing flavors contain artificial flavoring. As required by 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accompanied by the word(s) "artificial" or "artificially flavored", in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., "artificial vanilla", "artificially flavored strawberry", or "grape artificially flavored". Your label bears declarations of the flavors passion fruit, watermelon, and apple and your products contain natural and artificial passion fruit flavor, artificial watermelon flavor, and natural and artificial apple flavor. However, the names of these three characterizing flavors on your labels are not accompanied by the word(s) “artificial” or “artificially flavored.”
11. Your Passion Fruit Italian Water Ice (6 fl. oz.), Cry Baby Sour Watermelon Water Ice (6 fl. oz.), and Cry Baby Sour Apple Italian Ice (6 fl. oz.) product labels are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not declared in accordance with 21 CFR 101.9 Specifically, your product labels fail to declare the amount of saturated fat in a serving or if a statement of the saturated fat is not required, your labels do not contain the statement “Not a significant source of saturated fat” at the bottom of the table of nutrient values as required by 21 CFR 101.9(c)(2)(i).
This letter may not list all the violations in your product labeling or at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, further guidance and information on food allergens can be accessed on FDA’s website at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm and http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
We acknowledge that your firm has voluntarily recalled 4,224 cases/12-6oz. cups/case of your distributed Cry Baby Sour Watermelon Water Ice product because it contains an undeclared, certified color additive, specifically FD&C Yellow No. 5. In addition, we acknowledge that on June 28, 2012, your firm voluntarily destroyed 2,788 cases of this product, and that on or about August 3, 2012, your firm provided our recall coordinator with documentation that the remaining 1,436 cases were destroyed at their individual locations. However, these actions fail to correct all of the violations noted above.
You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
We also note that the net weight for your Passion Fruit Italian Water Ice (6 fl. oz.) product should be followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. Your label only declares net weight in fluid ounces.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director