Hahn's Old Fashioned Cake Company, Inc. 4/17/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
April 17, 2014
WARNING LETTER NYK-2014-28
VIA UNITED PARCEL SERVICE
Mrs. Regina Hahn, President and Co-Owner
Hahn’s Old Fashioned Cake Company, Inc.
75 Allen Boulevard
Farmingdale, NY 11735
Mr. Andrew M. Hahn, Vice President, Secretary and Co-Owner
Hahn’s Old Fashioned Cake Company, Inc.
75 Allen Boulevard
Farmingdale, NY 11735
Dear Mr. and Mrs. Hahn:
On January 8, 2014 through January 14, 2014, U.S. Food and Drug Administration (FDA) investigators inspected your manufacturing facility, located at 75 Allen Boulevard, Farmingdale, New York. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These conditions cause the food products held at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
In addition, our inspection revealed that your Cranberry-Orange Pound Cake and Pumpkin Pound Cake products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)], as well as misbranded within the meaning of section 403 of the Act, [21 U.S.C. §343].
You may find the Act through links on FDA’s Internet home page at www.fda.gov
We received your firm’s response to the form FDA-483, Inspection Observations, dated January 29, 2014, and our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to, the following:
Current Good Manufacturing Practices
1. Failure to maintain equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1). Specifically,
- Your cleaning process for the batter transfer pump, a direct food contact surface, does not include an appropriate cleaning or sanitizing step on large components that cannot be disassembled (i.e. – the plastic tube that transfers the batter to the pump and the metal tube that transfers the batter from the pump to the hopper). You stated that large components of the batter transfer pump that cannot be disassembled are cleaned by placing a damp washcloth inside the tubing and pushing it through until the wash cloth emerges free of visible food residue. During your inspection the FDA investigators observed that you manufacture a Raspberry-Walnut Crumb Cake that contains walnuts, a major food allergen (tree nuts), as one of its ingredients. The aforementioned method is not an appropriate cleaning or sanitizing step to prevent cross contamination of allergens from that equipment to other products you manufacture. In addition, the method is not adequate to prevent the growth of microorganisms.
- Your cleaning process for the crumb prep table does not include an appropriate cleaning or sanitizing step. You stated that the crumb prep table is cleaned by scraping the table with a piece of cardboard. This table is constructed of wood and was observed to be pitted and gouged. This method is not an appropriate cleaning or sanitizing step to prevent cross contamination of allergens and/or microorganisms from that equipment to other products you manufacture.
- Your finished product packaging line is neither cleaned nor sanitized, and was observed to be encrusted with flour, sugar, and filth. Additionally, finished product packaging is placed on the production line in such a way as to contribute to finished product contamination by the aforementioned substances.
- There is no sanitization step for equipment and utensils. Additionally, there were no sanitizing solutions observed on the premises by investigators during the course of the inspection.
Your response to this observation cannot be evaluated at this time. A subsequent inspection will be needed to verify your proposed corrective actions and to determine if your new cleaning and sanitization methods are effective. Additionally, it is unclear in your response if you are committing to the replacement of the crumb prep table made of wood with a stainless steel table.
2. Effective measures are not being taken to exclude pests from your processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on 01/08/2014, while your firm was manufacturing the following was observed:
- Six birds were observed flying around the production area.
- A bird was observed perched upon the batter mixer located in the south west corner of the building.
- A bird was observed defecating while perched on a rafter located above uncovered finished product.
- Several birds were observed perched above the finished product packaging area.
- \A dead and decomposing mouse was observed next to a mouse trap located adjacent to the mixing machine.
- A large gap, at least one inch wide, was observed at the bottom of the bay door leading directly into the production area. Additionally, gaps were observed along the top left hand side of the bay door.
Your response to this observation cannot be evaluated at this time. A subsequent inspection will be needed to verify your proposed corrective actions and to determine if they are effective in excluding pests from your facility.
3. The use of equipment and utensils fails to preclude the adulteration of food with lubricants, as required by 21 CFR 110.40(a). Specifically, on January 8,2014 lubricants from the cake slicer were observed dripping into a finished crumb cake.
Your response to this observation is inadequate. In your response you state that the lubricant described in the observation was a food safe release product called (b)(4). However, no supporting evidence was provided in your response or to the investigators during the inspection to substantiate this statement.
4. Employees who appear to have an open lesion are not excluded from operations where there is a reasonable possibility of food, food contact surfaces, and food packaging materials becoming contaminated, as required by 21 CFR 110.10(a). Specifically, on January 8, 2014 (b)(4) employees were observed to have open cuts on their hands while handling crumb topping without wearing gloves.
Your response to this observation is inadequate. Your response does not address the disposition of the product manufactured by your firm on January 8, 2014 while (b)(4) employees were observed to have open cuts on their hands while handling crumb topping without wearing gloves.
1. Your Pumpkin Pound Cake and Cranberry-Orange Pound Cake products are adulterated within the meaning of section 402(c) of the Act, 21 U.S.C. § 342(c), because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act, 21 U.S.C. § 379e(a). Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive 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 Pumpkin Pound Cake and Cranberry-Orange Pound Cake products are manufactured with FD&C Yellow No. 5; however, the labels for these products fail to declare the presence of FD&C Yellow No. 5 in the ingredient statements.
2. Your Pumpkin Pound Cake and Cranberry-Orange Pound Cake products are misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the products bear or contain an artificial flavoring, coloring, or chemical preservative, but fail to bear labeling stating that fact. Specifically, in accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Your Pumpkin Pound Cake and Cranberry-Orange Pound Cake products are manufactured with FD&C Yellow No. 5; however, neither product bears a label identifying the presence of these color additives. Under 21 CFR 101.22(k)(l), certified colors must be declared by the name of the color additive listed in the applicable regulation in Part 74 or Part 82 of this chapter. The common or usual name may be abbreviated to omit the “FD&C” prefix and the term “No.” (e.g., Yellow 5).
The aforementioned labeling violations were not addressed in your response. These violations were not included on your FDA-483, Inspectional Observations, dated January 29, 2014; however they were discussed during the course of the inspection of your facility.
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
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 such as verification records, 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.
This letter may not have listed all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 C.F.R. Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 USC 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 USC 379j-31(a)(2)(B)]. 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.
Your written response should be sent the Food and Drug Administration; Attention: LCDR Frank Verni, RPh; U. S. Food and Drug Administration; Compliance Branch; 158-15 Liberty Avenue, Room 4050; Jamaica, NY 11433.
If you have any questions about the content of this letter please contact: LCDR Verni at (718) 662-5702.
Ronald M. Pace
New York District