Inspections, Compliance, Enforcement, and Criminal Investigations
Quality Formulation Laboratories, Inc. 13-Jul-07
Department of Health and Human Services
Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
July 13, 2007
File # 07-NWJ-13
Dr. Mohamed Desoky
President and Chairman
Quality Formulation Laboratories, Inc.
110 Pennsylvania Avenue
Paterson, NJ 07503
Dear Dr. Desoky:
The Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 110 Pennsylvania Avenue, Paterson, New Jersey, on January 25, 26, 29, 30 and February 1, 6 and 12, 2007. Our review of your labeling and other evidence collected by our investigators demonstrate that your Egg Protein III Vanilla powder mix and your American Sports Nutrition™ MAJOR EGG™ powder mixes (in Double Chocolate, Vanilla and Wildberry flavors) violate the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
Your Egg Protein III Vanilla powder mix is misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act [21 U.S.C. 343(a)(1) and 321(n)], in that the labeling is misleading for failing to reveal facts material to consequences that may result from the use of the article. You do not represent that your product contains milk protein; however, analytical testing has shown that some lots of the product do contain milk protein. FDA has also received reports regarding consumer reactions by milk-allergic consumers who consumed this product.
Your Egg Protein III Vanilla powder mix product is also adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] in that it has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health, Specifically, our inspection of your facility revealed the following sanitation deviations:
1. In order to comply with 21 CFR 110.35(d), all food contact surfaces, including food contact surfaces of equipment, must be cleaned with sufficient frequency to prevent the contamination of food. However, our inspection revealed that your firm's cleaning procedure consisted solely of using [redacted] air and [redacted] to remove product residue between batches, irrespective of whether products without allergenic ingredients were manufactured subsequent to batches containing allergenic ingredients.
Similarly, although your batch records indicate that a [redacted] cleaning was performed between batches and your "S.O.P. for Cleaning" indicates a [redacted] of blenders is to be performed, no such cleaning was observed during the course of our inspection. Further, your Blending Room Supervisor advised our investigators that he only performed a dry cleaning (as described above) between batches and did not know why he indicated on the batch records that a wet cleaning was performed between batches.
Furthermore, our laboratory analyses of your Egg Protein III powder mix (from Lot #'s 60833 and 60853) found the presence of undeclared milk protein. Records collected by our investigators showed that in each instance, a product containing whey, which contains milk protein, was manufactured on the same equipment, either immediately preceding the lot (Lot# [redacted]), or three lots prior (Lot# [redacted]) Your lack of adequate cleaning procedures does not provide assurance that cross-contact will not occur between products that contain allergens and those that do not contain allergens.
2. In order to comply with 21 CFR 110.80(b)(1), equipment and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Our investigators observed excessive accumulations of old product residues on blenders, product staging areas, on the interior and exterior of purportedly clean blenders and on environmental surfaces throughout the manufacturing area.
3. In order to comply with 21 CFR 110.80(b)(2), all food manufacturing, including packaging and storage, must be conducted under such conditions and controls as are necessary to minimize the potential for the contamination of food (e.g., contamination with the allergenic-ingredient milk in non-milk containing products). We observed excessive accumulation of old product residue not only on the product equipment but also on the inside of the plastic bags that were staged at the filler and on drums that were to be used to hold finished product.
Your American Sports Nutrition™ MAJOR EGG™ powder mixes (in Double Chocolate, Vanilla and Wildberry flavors) are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)], in that the labels fail to declare the common or usual name of each ingredient. Specifically, our inspection revealed that you changed the product formulation for your MAJOR EGG™ powder mixes in June of 2006 to include a whey ingredient; however, you did not update your labels to disclose the presence of whey.
Your American Sports Nutrition™ MAJOR EGG™ powder mixes (in Double Chocolate, Vanilla and Wildberry flavors) are further misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare all major food allergens present in the product, 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:
1. 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 ingredient, [section 403(w)(1)(A) of the Act, 21 U.S.C. 343(w)(1)(A)],
2. 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., "whey (milk)"), 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 or the name of the food source appears elsewhere in the ingredient 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)].
During the inspection you advised our investigators that, although you were aware of FDA's regulations regarding the declaration of allergens on food labels, you choose to continue to use your inaccurate, existing label stock due to cost considerations.
Furthermore, we note that on January 31, 2007, your firm issued a press release announcing a voluntary recall of all Major Egg products due to undeclared milk. In the memo, it states that for the next production of Major Egg products, the label will be changed to a new one declaring that the product contains milk as an allergen. A temporary correction is apparently being made by adding a sticker to the product using the old label. The sticker is being added underneath the ingredient statement and some additional intervening materials. As of July 13, 2007, FDA has not received any additional information regarding a labeling correction plan. Please note that a "Contains Milk" sticker is not a suitable correction because the ingredient statement still fails to declare the whey ingredient. Also, the "Contains" statement must be followed by all of the major allergens found in the product (e.g., "Contains egg, milk"). Guidance on the allergen labeling requirements in section 403(w) may be found on FDA's website at www.cfsan.fda.gov/-dms/wh-alrgy.html.
We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating. Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these deviations. You should include in your response documentation such as revised labels, revised procedures, and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining deviations.
This letter may not list all deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act, the Current Good Manufacturing Practice regulations and FDA's food labeling requirements. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your reply should be sent to the Food and Drug Administration, New Jersey District Office, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attention Richard D. Manney, Compliance Officer. If you have any questions, please contact Mr. Manney at (973) 331-4908.
Douglas I. Ellisworth
New Jersey District