Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Waterview Corporate Center|
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4910
April 2, 2012
VIA UPS OVERNIGHT
Mr. Alexander M. Rogers
Theta Brothers Sports Nutrition, Inc.
dba Protein Factory
644 Cross Street
Lakewood, New Jersey 08701
File No.: 12-NWJ-16
Dear Mr. Rogers:
On October 11 through November 8, 2011, an investigator from the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 644 Cross Street, Units 6 & 7, Lakewood, NJ. The inspection revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. You may find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.
Our inspection of your facility revealed the following violations of the dietary supplement CGMP regulation (21 CFR Part 111):
1. You failed to adequately clean equipment and utensils to protect components and dietary supplements from being contaminated by any source, as required by 21 CFR 111.27(a)(3)(v). Specifically, the production procedures your firm uses in manufacturing dietary supplements are not adequate to ensure that preceding products do not contaminate subsequent products. You failed to clean equipment between production of some of your products, including products containing allergens such as eggs and milk. For example, our investigator found that you manufactured your Egg White Protein product followed by non-egg containing products (WPC/Dextrose Vanilla).
2. You failed to verify that your finished batches of dietary supplements meet product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch, as required by 21 CFR 111.75(c). You may verify that these specifications are met by testing or examining, 1) every finished batch, or 2) a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. If you test a subset of finished batches, you must identify the subset using a sound statistical plan [21 CFR 111.75(c)]. Because you did not identify such a subset of finished batches, you must test every finished batch of the dietary supplements manufactured at your firm . However, our investigator found that you did not conduct finished product testing on any products you manufacture.
3. You failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70. Specifically:
a. You failed to establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Our investigator found that although you have written procedures for establishing component specifications, you in fact accept components from your supplier without establishing your own specifications for those components.
b. You failed to establish product specifications for the identity, purity, strength, and composition of some of the dietary supplement products manufactured at your facility, as required by 21 CFR 111.70(e). Those dietary supplement products include Rifle Protein Vanilla, PeptoPro Lemon Lime, WPC/Dextrose Vanilla, CFM Whey Isolate, Goat Whey Protein Concentrate, and Custom Protein Factory Mix.
In addition, we note that manufacturers are responsible for more than establishing specifications. Once you have established the specifications under 21 CFR 111.70, you must determine whether the specifications have been met [21 CFR 111.73].
4. You failed to follow the requirements for batch production records (BPRs), as required by 21 CFR 111.255 and 111.260. Specifically:
a. You did not prepare a BPR every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255(a). Specifically, our investigator found that there were no BPRs prepared for approximately 100 custom order products manufactured by your firm in October 2011 . These products include, but are not limited to: CFM Whey Isolate, Lot #54382; Goat Whey Protein Concentrate, Lot #54371; Custom Protein Factory Mix, Lot #54407 and Custom Protein Factory Mix, Lot #54384.
b. For those products for which you did prepare a BPR, the BPR failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260.
i The BPRs for Pure Vanilla 2 lb. and Pure Chocolate, Lot #31700912, Rifle Protein Vanilla, Lot #34360405 and Whey Light Chocolate, Lot #38820803 did not include the unique identifier (lot #) that you assigned for each component, the packaging used and the label used [21 CFR 111.260(d)]. Furthermore, a unique identifier is not assigned to each finished product lot. For example, lot# 39301020 was assigned to seven different finished products manufactured on 10/19/2011, specifically Egg White Protein Natural Vanilla, WPC/Dextrose Vanilla, Creapure Creatine Monohydrate, Glutamine Peptides, WPC Vanilla, WPC Chocolate, and 100% Oat Muscle;
ii. The BPRs for Pure Vanilla 2 lb. and Pure Chocolate, Lot #31700912, Rifle Protein Vanilla, Lot #34360405 and Whey Light Chocolate, Lot #38820803 did not include a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
iii. The BPRs for Pure Vanilla 2 lb. and Pure Chocolate, Lot #31700912, Rifle Protein Vanilla, Lot #34360405 and Whey Light Chocolate, Lot #38820803 did not include initials of the persons performing each step [21 CFR 111.2600)(2)];
iv. The BPRs for Pure Vanilla 2 lb. and Pure Chocolate, Lot #31700912, Rifle Protein Vanilla, Lot #34360405 and Whey Light Chocolate, Lot #38820803 did not include reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)]. Label reconciliation is required for cut or rolled labels if a 100-percent examination for correct labels is not performed by appropriate electronic or electro-mechanical equipment during or after completion of finishing operations [21 CFR 111.410(b)];
v. The BPRs for Pure Vanilla 2 lb. and Pure Chocolate, Lot #31700912, Rifle Protein Vanilla, Lot #34360405 and Whey Light Chocolate, Lot #38820803 did not include an actual label or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2)];
vi. The BPRs for Pure Vanilla 2 lb. and Pure Chocolate, Lot #31700912, Rifle Protein Vanilla, Lot #34360405 and Whey Light Chocolate, Lot #38820803 did not include documentation that quality control personnel reviewed the batch production record [21 CFR 111.260(1)(1 )] or released a batch for distribution [21 CFR 111.260(1)(3)] .
5. Your master manufacturing records (MMRs) for Rifle Protein Chocolate, Big Blast Chocolate, and Weight Loss MRP failed to include all the information required by 21 CFR 111.210. Specifically, your MMRs failed to include the measure of each dietary ingredient, as required by 21 CFR 111.210(a). Consequently, our investigator found that ingredients such as flavorings and the vitamin and mineral mix were adjusted by employees during production for each batch size. Our investigator found that the employees adjusted amounts of ingredients from memory based upon ratios learned from other employees.
6. Your firm failed to establish written procedures for identifying each unique lot within each unique shipments of components, as required by 21 CFR 111.153 and 111.155(d)(1). Our investigator also found that you did not meet the requirements of 21 CFR 111 .155(d)(1) in that you were unable to explain where various lot numbers came from (e.g ., the lot number on a drum labeled "Omega Muscle lot #1 033112"), and your batch record for Rifle Vanilla, lot #34360405, did not include a unique lot number for one of the product's ingredients.
7. You failed to use a unique identifier whenever you recorded the disposition of each unique lot within each unique shipment of components that you received and any lot of components that you produced, as required by 21 CFR 111.155(d)(2). Specifically, our investigator observed that finished Post Workout Chocolate and Carb Energy products in your firm's inventory were not identified with lot numbers.
8. You failed to make and keep required records related to quality control operations, as required by 21 CFR 111.140. Under 21 CFR 111.140(b)(2), you must make and keep records for fulfilling the requirements of subpart F, including written documentation that quality control personnel performed the review, approval, or rejection requirements. This subpart includes the requirement that you have quality control operations for approving, and releasing from quarantine, all components [21 CFR 111.120(e)]. Specifically, you were unable to produce documentation that quality control personnel performed the review, approval, or rejection related to approving components and releasing them from quarantine.
Furthermore, you failed to establish written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing as required by 21 CFR 111.103. Although you provided our investigator with a document that sets forth general procedures for quality control, you have no written procedures that specify how these functions are to be performed at your manufacturing facility. The document you provided does not establish responsibilities for any individuals at your facility.
9. You failed to use equipment of appropriate design and construction so that use will not result in the contamination of dietary supplements, as required by 21 CFR 111.27(a)(2). You also failed to maintain your equipment to protect components and dietary supplements against contamination from any source, as required by 21 CFR 111.27(a)(3)(v). Specifically, your firm is blending all products in (b)(4) commercial grade (b)(4) and one (b)(4) stock pots (i.e. soup pots), and mixing all powder blends with a handheld (b)(4) electric mixer. Our investigator observed that the (b)(4) stock pots were heavily scored, as was the (b)(4) stock pot. The (b)(4) stock pot was purchased during the period in which we conducted our inspection, and therefore became scored after only minor use. In addition, the mixing blade of the handheld mixer was chipped in several areas. As a result of this chipping and scoring, your equipment fails to protect your dietary supplement products from contamination from metal fragments. These practices also caused you to violate 21 CFR 111.365(i), which requires you to use effective measures to protect against the inclusion of metals in components or dietary supplements, by, for example, use of electronic metal detectors. On a similar note, you failed to establish written procedures for maintaining all equipment, as required by 21 CFR 111.25(c).
We have considered your response to these concerns, and determined it to be inadequate. During the inspection, you informed our investigator that you intended to correct these violations by telling your employees "not to hit the bottom of the pot with the mixer." This proposed corrective action will not sufficiently protect against contamination.
10. You failed to establish and follow written procedures for the requirements to fulfill the requirements of subpart 0, as required by 21 CFR 111 .553. Under 21 CFR 111.553, you must establish written procedures to fulfill the requirements of subpart 0. This subpart includes the requirement that a qualified person must review all product complain.ts to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications [21 CFR 111.560(a)(1)]. However, no qualified person investigated complaints you received regarding brown spots in your Native Whey, PO/lot 47044 and the consistency and flavor in your Membrane Micellar Casein PO/lot, 39083. Furthermore, products returned to your firm for similar complaints, such as consistency or taste, were not always designated as complaints.
In addition, although you provided our investigator with procedures related to the handling of complaints, these procedures were not specific to operations at your facility.
11. You failed to establish specifications for your dietary supplement labels, as required by 21, CFR 111.70(d). Specifically, our investigator found that you do not have label specifications for all of your products.
12. You failed to make and keep records of a material review and disposition decision on a returned dietary supplement, as required by 21 CFR 111.535(b)(2). Specifically, the records you provided to our investigator do not document any material review and disposition decision for 32 dietary supplements returned to your firm.
13. You failed to make and keep adequate documentation of calibrations for instruments you use in manufacturing components in your dietary supplements, as required by 21 CFR 111.35(b)(3). Among other requirements, your documentation must identify the instrument or control calibrated; identify the reference standard used; identify the calibration method used, including appropriate limits for accuracy and precision; and provide the calibration reading or readings found [21 111.35(b)(3)(i)-(v)]. However, you do not have calibration records for the (b)(4) scales (b)(4) electronic scale (b)(4) and (b)(4) and (b)(4) from you firm uses.
1. Your products, Penta Protein, Big Blast (b)(4) Chocolate Peanut Butter, Rifle, Anabolic Cream, (b)(4) and (b)(4) are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all known major food allergens as specified by the Act.
Section 201(qq) of the Act 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 food, 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., "whey (milk)"), except that the name of the food source is not required when either the common or usual name 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)].
Specifically, our review of the above labels revealed the following:
• Penta Protein contains whey, soy, and egg proteins. The labeling fails to contain the required allergen warning for soy and egg and is improperly labeled for milk allergen;
• Rifle (chocolate and vanilla) contain whey and egg proteins. These products are labeled improperly for milk and egg allergens in that the labeling states "Contains dairy ingredients";
• Anabolic Cream (Bourbon Vanilla), (b)(4) and Rifle products contain ingredient "LS321" which is manufactured with maltodextrin (wheat), milk protein, and soy lecithin. None of the products are labeled properly for the allergens of soybeans or wheat;
• Anabolic Cream (Bourbon Vanilla) and lonics products contain whey. Neither product is labeled for milk allergen;
• (b)(4) Cinnnabun contains whey but fails to include an allergen statement;
• (b)(4) contains whey protein. The labeling fails to contain the required allergen warning for milk allergen.
Further guidance and information on food allergens can be accessed on FDA's website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
2. Your Anabolic Cream (Chocolate Milk and Bourbon Vanilla flavors), Penta Protein, (b)(4) and Super Plasma products are misbranded within the meaning of sections 403(i)(1) and 403(s)(2)(B) of the Act in that the labels fail to identify the products 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 that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product.
3. Your (b)(4) Protein, (b)(4) Penta Protein, (b)(4) Nutritional Supplement (b)(4) Complete Protein Powder, (b)(4) Complete Protein Powder, and (b)(4) are misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of nutrition information on the labeling for your products does not comply with 21 CFR 101.36. For example: Protein Powder, Complete Protein Powder;
• The following dietary supplement product labels bear "Nutrition Facts" panel, not the required "Supplement Facts" panels: (b)(4) Protein, (b)(4) Penta Protein (b)(4) Nutritional Supplement (b)(4) Complete Protein Powder, (b)(4) and (b)(4) Complete Protein Powder.
• The Supplement Facts panel for (b)(4) Frosty Vanilla, fails to include % Daily Values for all dietary ingredients for which a daily value has been established, such as Vitamin A, Vitamin E, Magnesium, Potassium, and Zinc;
• The (b)(4) Complete Protein Powder, (b)(4) Post Workout Recovery Chocolate, Protein Factory Anabolic Cream Chocolate Milk, and (b)(4) product labels do not contain "Supplement Facts" information in the format required in accordance with 21 CFR 101.36.
4. Your (b)(4) Pure Egg White Protein, (b)(4) Grape, (b)(4) Fruit Punch and (b)(4) Hydrolyzed Whey Protein Vanilla are misbranded within the meaning of section 403(e) of the Act [21 U.S.C. § 343(e)] because the product labels fail to completely or accurately declare the place of business, street address, city, state and zip code as required by 21 CFR 101.5(d).
5. Your (b)(4) Complete Protein Powder, (b)(4) Complete Protein Powder, (b)(4) and (b)(4) are misbranded within the meaning of Section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the net quantity of contents is not listed in accordance with 21 CFR 101.105.
6. Your (b)(4) Complete Protein Powder, (b)(4) Complete Protein Powder, (b)(4) Chocolate (b)(4) Meal Replacement Vanilla Ice Cream and (b)(4) are misbranded under section 403(y) of the Act in that the labels fail, to include a domestic address or domestic phone number through which the responsible person (as described in section 761(b)) may receive a report of a serious adverse event with such dietary supplement.
The above violations are not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products are in compliance with the Act and FDA's implementing regulations. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to promptly correct the violations may result in enforcement action without further notice, such as seizure and/or injunction.
In addition to the above violations, we have the following comments:
• You failed to make and keep documentation, including the person(s) trained, to ensure that each person engaged in the manufacturing, packaging, labeling, or holding, or in performing any quality control operations, has the education, training, or experience to perform the person's assigned functions, as required by 21 CFR 111.14(b)(2) and 111.12(c). Although you signed two documents stating that training took place for "prevention of microbial contamination" and "manufacturing dietary supplements," your documentation did not specify who was trained.
• You failed to make and keep documentation of the date of the use, maintenance, and cleaning of equipment, unless such documentation is kept with the batch record, as required by 21 CFR 111.35(b)(2). Specifically, your firm failed to make and keep regular documentation of these functions for equipment other than an electric mixer.
• Your (b)(4) High Protein Whey Botanical Blend Wild Vanilla and Mocha products contain the claim "Anti-oxidant enriched", but it is not in accordance with 21 CFR 101.54(e). There is no DRV or RDI established for it and the antioxidant ingredient is NOT identified.
• Your Protein Factory Zip product contains an unsafe ingredient (desiccated thyroid gland extract) and the source is not listed. The term "dietary ingredient" does not include substances which humans avoid ingesting because they are not safe. Regulations prohibit thyroid glands from use as human food (9 CFR 310.15).
Within 15 working days of your receipt of this letter please notify this office of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show corrections. If you cannot complete all corrections within 15 working days, state the reason for the delay and the date by which you will correct any remaining violations.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions regarding any issue in this letter, please contact Ms. Della Fave at (973) 331-4910.
New Jersey District