| Public Health Service Food and Drug Administration |
Southwest Region |
Department of Health and Human Services
September 9, 2011
Ref: DEN-11-19 WL
WARNING LETTER
VIA UPS OVERNIGHT MAIL
Paul Anthony White II, Co-Owner/President
Tiffany A. Moore, Co-Owner/Vice President
Michele F. Lisco-Ediss, Co-Owner/Treasurer
Nutrition Center, Inc.
dba Nutri-West
2132 East Richards Street
P.O. Box 950
Douglas, WY 82633-0950
Dear Mr. White:
On April 25-29, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 2132 East Richards Street, Douglas, Wyoming. Our investigators found a number of violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. You can find the Act and FDA regulations through links on FDA's home page at http://www.fda.gov.
Adulterated Dietary Supplements
The inspection revealed that your DSF Formula, Total Arginine, Total Eyebright-M, Total Children's Chewable, Total Male, Total Inflam, Total Green, Total Probiotics, and Core Level Health Reserve products manufactured in your facility, are adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that these dietary supplements have been prepared, packed, or held lmder conditions that do not meet current good manufacturing practice regulations for dietary supplements. These observations were presented to you in an FDA-483 at the conclusion of our inspection on April 29, 2011.
The inspection revealed the following violations:
1. You failed to include in your written master manufacturing record (MMR), specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of your dietary supplement, as required by 21 CFR 111.210(h)(1). Specifically, you do not list in your MMR for the following products, DSF Formula, Core Level Health Reserve, Total Probiotics, Total Green Protein Powder, Total Inflam, Total Male, Total Children's Chewable, Total Eyebright-M, and Total Arginine:
(b)(4)
Without specifications for the steps in the manufacturing process where control is necessary listed in a MMR, you camlot ensure the quality of your dietary supplements.
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. You did not provide revised MMRs to document your proposed correction of the above violation. In addition, the revised MMR for Adreno Lyph 160 (exhibit 1 in our response) did not provide an appropriate specification for drying. (b)(4)
2. Your batch production records (BPRs) did not include complete information relating to the production and control of each batch of your Total Arginine (b)(4) Total Probiotics (b)(4) DSF Formula (b)(4) Total Inflam (b)(4) Total Children's Chewable (b)(4) Total Green Protein Powder (b)(4) and Total Eyebright M (b)(4) dietary supplement products, as required by CFR 111.255(b). Specifically, your BPRs did not include the following required information:
• Documentation that finished product meets specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i).
• The weight or measure of each components used, as required by 21 CFR 111.260(e).
• A statement of the actual yield and a statement of the percentage oftheoretical yield at appropriate phases of processing (e.g., compression, milling, filling, wetting) as required by 21 CFR 111.260(f).
• The actual results which were obtained during the monitoring of the operation (e.g., drying, filling), as required by 21 CFR 111.260(g).
• Documentation for the completion of (including individual signatures for) manufacturing operations including but not limited to milling, blending, and wetting as required by 21 CFR 111.260(j)(2).
• Documentation, at the time of performance, that quality control personnel reviewed the BPR, and approved and released, or rejected, the batch for distribution as required by 21 CFR 111.260(1)(1) and (3).
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. Exhibit 2 to your response indicates that you will use a Batch Record Review & Release Porm to meet the requirement under 21 CFR 111.260(1)(1) and (3); however, your proposed new form in Exhibit 2 did not address any of the other batch record requirements listed in the above violation. While you discussed the other batch record requirements in your response, you did not provide any documentation of corrections regarding these requirements.
3. Your firm failed to provide records to show that you had established specifications as required by 21 CFR 111.95(b)(1) as follows:
• Component identity specifications for each component used in the manufacture of the dietary supplement, as required by 21 CFR 111.70(b)(1);
• Specifications for each component necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2);
• 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 supplement 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);
• 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);
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. Your response indicates that it will take (b)(4) to establish and document these specifications. We find these timeframes unacceptable.
4. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1).
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. Your response indicates that it will take (b)(4) to establish tests and examinations to verify the identity of dietary ingredients. We find these timeframes unacceptable.
5. Your firm failed to conduct appropriate testing of finished batches of dietary supplements to determine whether such dietary supplements met established specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). As discussed above, you must establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)). Once you have established product specifications, you must determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c).
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. Your response did not indicate how you would verify the identity, purity, strength, and composition of the finished dietary supplement products. You also indicated that it would take approximately (b)(4) to complete this process. We find these timeframes to be unacceptable.
6. Your firm failed to calibrate instruments you use in manufacturing or testing a component or dietary supplement at routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument, as required by 21 CFR 111.27(b)(3). Our investigator reviewed your previous arumal calibration records for (b)(4) for balances (b)(4) and found them to be outside of specified tolerances. There is no assurance that these balances were within calibrated tolerances prior to your last annual calibration on (b)(4)
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. Your response did not indicate that you calibrated the above balances and you provided no documentation that the balances were recalibrated within tolerances. Also, we find your timeframe of (b)(4) to implement routine calibration to be unacceptable.
7. Your batch record does not accurately follow the appropriate master manufacturing record and you did not perform each step in the production of the batch, as required by 21 CFR 111.255(c). Specifically, our investigator observed the following deviations in the manufacturing of the Complete Glutathione dietary supplement, (b)(4)
o Employees added raw material items (b)(4) to work in the process material from (b)(4) of the batch record rather than only adding material (b)(4) and then blended the material for (b)(4). The directions from (b)(4) are to add items (b)(4)
o For (b)(4) the batch record directions are to (b)(4). The employees did not add (b)(4) as directed.
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. You provided documentation to show that your employees signed off on the disciplinary report, and read your manufacturing operations policies and procedures. However, you did not provide the manufacturing operations policies and procedures for us to review.
8. You failed to use effective measures to protect against the inclusion of metals or other foreign material in components or dietary supplements as required by 21 CFR 111.365(i). Specifically, your firm's manufacturing processes for tablets and capsules do not include the use of filters or strainers, traps, magnets, electronic metal detectors, or any other comparable means to protect against the inclusion of metal or other foreign materials from equipment such as (b)(4)
We have reviewed your response dated May 17, 2011 and determined it to be inadequate. While Exhibit 4 to yom response included a purchase order for (b)(4) you did not include any documentation of your implementation of this (b)(4) in your facility.
Misbranded Dietary Supplements:
Your products, DSF Formula, Total Probiotics, Total Inflam, Total Children's Chewable, Total Green Protein Powder, Total Arginine, and Total Eyebright-M are misbranded under section 403(q)(5)(F) of the Act [21U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36.
Examples of your violations of the requirements of 21 CFR 101.36 include:
• Your products Total Inflam and Total Eyebright-M do not present nutrition information in a panel entitled "Supplement Facts," and enclosed the nutrition information in a box using hairline, as required by 21 CFR 101.36(e)(1) and (e)(2), respectively;
• None of the products' labels separate each dietary ingredient listed on the labels above and beneath it by a hairline rule centered between the lines of text, as required by 21 CFR 101.36(e)(5).
• None of the products' labels include any of the bars required by 21 CFR 101.36(e)(5)-(7) to separate sections of the Supplement Facts panels.
We received your response to the FDA-483, dated May 17, 2011. In your response, you indicated that you would correct the above violations and you provided dates by which you would correct each violation. However, you failed to provide sufficient documentation of your changes for our review. Without appropriate documents to review, we cannot assess your corrective actions.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
In addition, we note the following regarding your firm's operation:
1. Your firm's quality control operation failed to approve and release from quarantine all components before they were used, as required by 21 CFR 111.120(e).
2. Your firm failed to maintain documentation of how you qualified your suppliers, as required by 21 CFR 111.75(a)(2)(ii)(C) and failed to periodically re-confirm your supplier's certificates of analysis, as required by 21 CFR 111.75(a)(2)(ii)(D). Further, your quality control personnel failed to review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier, as required by 21 CFR 111.75(a)(2)(ii)(E).
3. You failed to include in your MMRs the following information required by 21 CFR 111.210:
• Written instructions for procedures for sampling, as required by 21 CFR 111.210(h)(2).
• Written instructions for corrective actions plans when a specification is not met, as required by 21 CFR 111.210(h)(5).
4. Your dietary supplements DSF Herbal (b)(4) Magnesium Chelate (b)(4) and Multibalance for Women (b)(4) failed to meet labeled claims for the nutnents Vitamin B6, Magnesium, and Riboflavin, respectively, your quality control personnel did not reject or reprocess these dietary supplements, nor did they approve a treatment, or in-process adjustment to ensure the quality of the finished dietary supplements and to ensure that the dietary supplements were packaged and labeled as specified in your MMR, as required by 21 CFR 111.77(a) and 111.113(b)(2).
Please advise this office in writing within 15 days from your receipt of this letter 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 that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Carolyn A. Pilmey at (303) 236-3024.
Sincerely,
/s/
Ann M. Adams, Ph.D.
Acting Denver District Director
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