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WARNING LETTER

American Pure Whey May 24, 2016

American Pure Whey - 05/24/2016


Recipient:
American Pure Whey


United States

Issuing Office:
Atlanta District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Atlanta District Office
60 8th St., NE
Atlanta, GA 30309 

 

May 24, 2016
 
 
VIA UPS OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
 
Mr. Abishek Krishnan, Owner 
American Pure Whey, LLC
4441-106 Six Forks Road
Raleigh, NC 27609
WARNING LETTER
(16-ATL-10)
 
Dear Mr. Krishnan,
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 3914-E US Highway 70E in New Bern, North Carolina, from September 15-18, 2015.  During the inspection, we collected labels for your American Pure Whey 100% Pure Whey Matrix Chocolate. We also collected a sample of your American Pure Whey 100% Whey Protein Matrix Chocolate product for analysis by the FDA’s Southeast Regional Laboratory. The results of the laboratory analysis and label review for your American Pure Whey 100% Whey Protein Matrix Chocolate product reveal this product is misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343].  In addition, the inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, found in Title 21 of the Code of Federal Regulations Part 111 (21 CFR Part 111). These violations render dietary supplements that are manufactured in your facility adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)], in that such products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
 
You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.
 
We received your written response letters, dated September 29, 2015, and March 23, 2016. We have reviewed your responses, and we address your proposed corrective actions below.
 
Dietary Supplement CGMPs
 
A review of the label for your American Pure Whey 100% Pure Whey Matrix Chocolate includes directions for use for the product “[a]s a dietary supplement.” As discussed further below, this product is not properly labeled as a dietary supplement. If you intend to market this product as a dietary supplement, it must comply with the applicable statutory and regulatory requirements, including 21 CFR Part 111 and the nutrition labeling requirements under 21 CFR 101.36.  Based on FDA’s observations during the inspection of your facility, if this product were a dietary supplement, it and any other dietary supplements you manufacture would be adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the following CGMP regulations for dietary supplements:
 
1.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. Specifically, you do not have any written procedures for quality control operations. You must establish quality control procedures consistent with the requirements outlined in 21 CFR 111.105, and you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65.
 
We have reviewed your September 29, 2015, and March 23, 2016, responses for this observation; however, we are unable to evaluate the adequacy of your corrections because you have not provided evidence that you have established and implemented the required quality control procedures.
 
2.    You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you have not prepared an MMR for each of the dietary supplement products that you manufacture that satisfies the requirements of 21 CFR 111.210. You must prepare an MMR for each of the dietary supplements that you manufacture that satisfies the requirements of 21 CFR 111.210, and you must make and keep MMRs as required by 21 CFR 111.205(c).
 
We have reviewed your September 29, 2015, and March 23, 2016, responses for this observation; however, we are unable to evaluate your corrective actions because you have provided only one sample MMR for your Whey protein isolate, Chocolate product, and it does not meet the requirements of 21 CFR 111.210.  Specifically, it does not include the following:
 
a.    a statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)],
b.    A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)], and
c.    Written procedures for sampling in the MMR and a cross reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
                                          
Additionally, in order for us to fully evaluate your corrective action, you will need to provide the MMRs for all dietary supplement products that you manufacture.
 
3.    You failed to establish the required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). You do not have written specifications to ensure the consistent production of your finished dietary supplements. Specifically:
 
a.    You failed to establish the following required component specifications for each component that you use in the manufacture of a dietary supplement:
i.    Identity specifications [see 21 CFR 111.70(b)(1)];
ii.    Component specifications that are necessary to ensure that specifications for the purity strength, and composition of dietary supplements manufactured using the components are met [see 21 CFR 111.70(b)(2)]; and
iii.    Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [see 21 CFR 111.70(b)(3)].
 
b.    You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1).
 
c.    You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
 
Once you have established component and product specifications, you must verify that the specifications are met in accordance with 21 CFR 111.75. Further, you must make and keep records for established specifications in accordance with 21 CFR 111.95(b)(1). 
 
We have reviewed your September 29, 2015, and March 23, 2016, responses for this observation; however, we are unable to evaluate the sufficiency of your corrective action because you failed to provide evidence that you have established component, in-process, or finished product specifications. 
 
4.    You failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255. Specifically, you do not make or keep batch records for any of your dietary supplement products. You must prepare a BPR for each of the products you manufacture that meets the requirements outlined in 21 CFR 111.260.
 
We have reviewed your September 29, 2015, and March 23, 2016, responses for this observation; however, we are unable to determine the sufficiency of your corrective action because you failed to provide documentation including production records that satisfy the requirements in 21 CFR 111.260
 
5.    You failed to examine, before labeling operations, labels for each batch of dietary supplement to determine whether labels conform to the master manufacturing record, in accordance with 21 CFR 111.410(c). Specifically, you do not review incoming labels against the master label for accuracy.  
 
We have reviewed your September 29, 2015, response for this observation, and we are not able to evaluate the adequacy of your corrective measures because you failed to provide evidence that you are documenting label reviews.
 
6.    You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). You do not collect samples for each of your finished products.
 
We have reviewed your September 29, 2015, response for this observation; however, we are unable to evaluate the sufficiency of your corrective action. In your response you state that you will hold samples of each batch manufactured for (b)(4) after the date of the batch, but you have not provided any supporting documentation regarding your collection and holding of reserve samples, such as a reserve sample log or photographs of reserve samples. Additionally, in your response you state that you will hold samples for (b)(4) after the expiration date of the batch. Under 21 CFR 111.83(b)(3) reserve samples must be held for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample.
 
7.    You failed to conduct all manufacturing operations in accordance with adequate sanitation principles, as required by 21 CFR 111.360. Specifically, you do not know the amount of cleaning agents added to your cleaning solutions, nor do you have any written procedures on how you clean and sanitize your manufacturing area and equipment. You must also make and keep record of written procedures for manufacturing operations, including sanitation practices, in accordance with 21 CFR 111.375. 

We have reviewed your March 23, 2016, response for this observation; however, we are unable to evaluate the sufficiency of your corrective action. You have provided a document titled, “(b)(4).” We are unable to determine its adequacy in meeting the requirements of 21 CFR 111.360 because only the cover page of the procedure was provided. The cover page does not describe the requirements for how you clean and sanitize your manufacturing area and equipment. Additionally, the cover page cross references (b)(4), but this procedure was not provided.
 
8.    You failed to establish and follow written procedures for your packaging and labeling operations, as required by 21 CFR 111.403 and 21 CFR 111.430(b). Specifically, you have no written procedure for matching manufacturing codes to the appropriate finished product label to ensure for the proper packaging and labeling of dietary supplements. 
 
9.    You failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you did not have written procedures for handling any returned dietary supplements, including when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520, or when a returned dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515. During the inspection, the Investigators observed approximately (b)(4) boxes of returned dietary supplements quarantined in your warehouse pending a disposition decision, but you have no written procedures for how to make a disposition decision regarding these or other returned dietary supplements. Please note that once you have established the required procedures, you must make and keep records for returned dietary supplements, as required by 21 CFR 111.535.
 
We have reviewed your September 29, 2015, and March 23, 2016, responses for this observation. We cannot evaluate the adequacy of your corrective action, as you have not provided evidence that you have established written procedures for the evaluation and disposition of returned dietary supplements. Additionally, for the 4 boxes of returned dietary supplements observed in quarantine during the inspection, you have not provided evidence that your quality control personnel conducted a review of the returns and made a deposition decision of these products.
 
10.    You failed to establish and follow written procedures for the requirements to review and investigate product complaints, as required by 21 CFR 111.553. Specifically, you have not established or followed written procedures for reviewing and investigating product complaints.
 
We have reviewed your September 29, 2015, and March 23, 2016, responses for this observation. We are unable to evaluate the adequacy of your corrective action because, although you mentioned that you are “working on standard operating procedure documentation” for complaints, you have not provided sufficient evidence that you have established a complaint procedure. Furthermore, the Customer Complaint Form you have provided in the response is not in compliance with 21 CFR 111.570(b)(2)(ii) because it does not include the name and description of the dietary supplement, the batch, lot, or control number of the dietary supplement, if available, and the date the complaint was received.
 
Misbranding
 
Your American Pure Whey 100% Whey Protein Matrix Chocolate product (b)(4) is misbranded under the following sections of Section 403 of the Act [21 U.S.C. § 343]:
 
1.    Your product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. During the inspection our investigators collected a sample (#918879) of American Pure Whey 100% Whey Protein Matrix Chocolate. Following the inspection, the product was submitted to the Southeast Regional Laboratory to be analyzed for protein and sugar content. The label for this product states that it provides 26 grams of protein per serving. However, our analysis found the protein content in the analyzed sample to (b)(4). Under 21 CFR 101.9(g)(4)(i), a food with a label declaration of protein is misbranded if the content of the nutrient (i.e., protein) is not at least equal to the value of the nutrient declared on the label of the product.

2.    Your product is 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 products, as required by section 403(w)(1) of the Act. The whey protein concentrate ingredient label discloses the allergens milk and soy, however, these allergens are not identified on the finished product label for products made from that ingredient.
 
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines a major food allergen as 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:
 
a.    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
 
b.    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., “flour (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 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)].
 
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
 
3.    Your product is misbranded within the meaning of section 403(i)(2) of the Act (the Act) [21 U.S.C. §343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). During the inspection the Investigator observed the manufacturing of the sampled product, including the addition of (b)(4) to the formulation; however these ingredients are not listed on the product label.
 
Additionally, our review of the label for your American Pure Whey 100% Pure Whey Matrix Chocolate shows that this product is not properly labeled as a dietary supplement. If you intend to market your product as a dietary supplement, it must comply with the applicable statutory and regulatory requirements for dietary supplements.  If this product were a dietary supplement, it would be misbranded for the following reasons:
 
1.     Your product would be misbranded within the meaning of section 403(s)(2)(B) of the Act [21 USC § 343(s)(2)(B)] because your product label fails to identify the product by using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product or an appropriately descriptive term.
 
2.     Your product would be misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that your product is a dietary supplement, and the label fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act, 21 U.S.C. § 379aa-1) may receive a report of a serious adverse event with such dietary supplements.
 
3.    Your product would be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] because it is labeled as a dietary supplement and is incorrectly labeled with a “Nutrition Facts” panel instead of a “Supplements Facts” panel as required by 21 CFR 101.36. Additionally, your product would be misbranding within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example:
 
a.    Your product has incorrectly calculated the percent Daily Value (DV) for (b)(2) dietary ingredients, for example, fiber and protein must be calculated as defined in 21 CFR 101.36(b)(2)(iii)(B) and 21 CFR 101.9(c).
b.    The Trans Fat should not be declared on the label if it is present in an amount that can be declared as zero in accordance with 21 CFR 101.36(b)(2)(i) and  21 CFR 101.9(c).
c.    The grams of fat do not appear to correspond appropriately to the number of calories. One gram of fat is equivalent to 9 calories. Because you declare 1 gram of fat on your label, the calories from fat declared should be 9.
 
 
This letter is not an all-inclusive list of the violations that may exist at your facility or in connection with your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are in compliance with all applicable statutes and regulations, including the Act and applicable FDA regulations.
 
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to implement lasting corrective actions may result in FDA taking regulatory action, including, without limitation, seizure or injunction.
 
In addition, we have the following comments:
 
1.    Your firm assigns an expiration date on your products. Any expiration date or equivalent term you place on a dietary supplement product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)]. Please note that the term “shelf life dating” includes shelf life dating, as well as expiration dating and “best if used by” dating [See 72 Fed. Reg. 34912, 34856 (Jun. 25, 2007).
 
2.    The ingredient list for your American Pure Whey 100% Pure Whey Matrix Chocolate is included in the nutrition label. According to 21 CFR 101.4(g) the ingredient list should be located immediately below the nutrition label, and should be preceded by the word “Ingredients,” unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 101.36(d), in which case the ingredients listed outside the nutrition label should be in a list preceded by the words “Other Ingredients.”
 
3.    Calories should be to the nearest 5-calorie increment up to and including 50 calories and to the nearest 10-calorie increment above 50 calories. (21 CFR 101.9(c)(1)).
 
4.    Trademark names, such as “Splenda” should not be included in the ingredient list.
 
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such corrective actions. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
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 reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990, x16 or write her at the noted address. 
 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
Sincerely,
/S/ 
Dawne M. Hines
Acting District Director
Atlanta District Office
 
cc:      
Modou L. Sanneh, Manager
American Pure Whey, LLC
3914-E US Highway 70E
New Bern, NC 28562