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U.S. Department of Health and Human Services

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Enforcement Actions

Precise Nutrition International, Inc. 7/11/13

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone:    949-608-2900
FAX:    949-608-4415

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
July 11, 2013
                                                                                                                                                                                                                                                                                                                                                         
 
Carl B. Silkensen                                                                                                                    W/L #44-13
President
Precise Nutrition International, Inc.
44300 Sun Gold Street
Indio, CA 92201
 
Dear Mr. Silkensen:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Precise Nutrition International, Inc. located at 44300 Sun Gold Street, Indio, CA from December 10, 2012 to December 21, 2012. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).  These violations cause your VitalErotic Shot dietary supplement product 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 the product has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. 
 
We received your written response on January 16, 2013 concerning our investigator’s observations noted on the Form FDA 483 that was issued to you on December 21, 2012.  Our comments regarding the adequacy of your response are detailed after the applicable violation, noted below.
 
Dietary Supplement CGMP Violations
 
1.    Your firm did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i), nor has FDA received a petition from you, and granted the petition, to exempt you from this testing requirement, as required by 21 CFR 111.75(a)(1)(ii).
 
Specifically, your firm manufactures the product VitalErotic Shot which contains the dietary ingredients L-Arginine HCL, L-Ornithine HCL, Gamma Amino Butyric Acid, Yohimbine HCL, Ascorbic Acid, Thiamin HCL, Niacin, Pyridoxine, and Cyanocobalamine. However, our investigator found that you did not conduct at least one test or examination to verify the identity of any of these dietary ingredients, as required by 21 CFR 111.75(a)(1). Rather, your firm relied on Certificates of Analysis (COAs) from your suppliers. A COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient. 21 CFR 111.75(a). You are required to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you successfully petition FDA for an exemption from such testing, 21 CFR 111.75(a)(1)(i). 
 
We reviewed your written response received on January 16, 2013 and found it to be inadequate. You stated that you revised and implemented written procedures to test the identity of incoming dietary components, including dietary ingredients.  However, you did not provide documentation showing that you implemented this corrective action.
 
2.    Your firm failed to establish the following specifications required by 21 CFR 111.70:
 
  • Component specifications for each component used in the manufacture of a dietary supplement to include:
o   Identity specifications [21 CFR 111.70(b)(1)];
o   Specifications to ensure the purity, strength and composition of the dietary supplements manufactured using these components are met [21 CFR 111.70(b)(2)]; and
o   Specifications that establish the 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 [21 CFR 111.70(b)(3)];
  • In-process production specifications for any point, step, or stage in the Master Manufacturing Record (MMR) where control is necessary to help ensure that specifications are met for the purity, strength and composition of the dietary supplements [21 CFR 111.70(c)(1)].
 
Specifically, your firm failed to establish specifications for any of the components used in your VitalErotic Shot dietary supplement product, including dietary ingredients L-Arginine HCL, L-Ornithine HCL, Gamma Amino Butyric Acid, Yohimbine HCL, Ascorbic Acid, Thiamin HCL, Niacin, Pyridoxine, and Cyanocobalamine, as required by 21 CFR 111.70(b)(1)-(3).
 
Additionally, your firm did not have a specification for the length of time bulk dietary supplement liquid can be stored in (b)(4) containers prior to filling. Your filling operations for VitalErotic Shot did not immediately follow your blending operations. Bulk dietary supplement liquid was observed to be stored in these containers from 11 days to 199 days between blending and filling.  You did not have a specification for the length of time bulk dietary supplement liquid will continue to meet finished product specifications after this storage period, as required by 21 CFR 111.70(c)(1). Further, you did not have any documentation to show that your products will continue to meet finished product specifications after this storage period.
 
We reviewed your written response received on January 16, 2013 and found it to be inadequate. You stated that changes have been made to your written procedures (“RMIS0190, Raw Material Identity Specification Sheet” and “CIS0191 Component Identity Specification Sheet”) and implemented.  However, you did not provide documentation showing that you implemented this corrective action. You also indicated that your firm has implemented a storage container stability study and provided a summary sheet of the analytical results from the ongoing study. However, this document does not provide details regarding the study such as the parameters of the study, the samples being collected, the method of collection, and the acceptance criteria for the study as a whole. 
 
3.    Your firm 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 that 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)].  However, the batch records for six of seven released lots of VitalErotic Shot collected during our inspection lacked documentation of any finished product testing to verify specifications for identity, purity, strength, and composition. Your procedures state that you perform an “active ingredient test” on every tenth batch of your finished product but you did not provide a statistical basis for this sampling plan.

 
We reviewed your written response received on January 16, 2013 and found it to be inadequate. Although you stated that you had “increased” testing frequency, your written procedures indicated that you will continue to test every tenth batch of your finished products and you provided no statistical basis for this sampling plan. You are required to verify that either every finished dietary supplement batch or a subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan meet the finished product specifications for identity, purity, strength, and composition [21 CFR 111.75(c)].  
 
4.    Your firm failed to qualify a supplier of a component by establishing the reliability of the supplier’s COAs through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). During the inspection, you confirmed that you did not qualify any of your suppliers of the components used in the manufacture of your VitalErotic Shot product or establish the reliability of your suppliers’ COAs.  At the time of inspection, you provided our investigator with COAs for Yohimbine HCL, Ascorbic Acid, and Niacin USP; however, no supplier qualification document was provided as required by 21 CFR 111.75(a)(2)(ii)(C). Pursuant to the requirements of 21 CFR 111.75(a)(2)(ii), such COAs may be used to determine whether component specifications, other than the identity of dietary ingredients, are met.
 
We reviewed your written response received on January 16, 2013 and found it to be inadequate. You indicated that the written specifications for reliability of suppliers have been revised and implemented in your written procedures.  However, you did not provide documentation showing that you implemented this corrective action and that personnel have been trained in this new procedure.   

5.    Your firm’s Master Manufacturing Records (MMR) for VitalErotic Shot failed to identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in your MMR, as required by 21 CFR 111.205(b)(1). Your MMR for VitalErotic Shot also failed to establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications identified, as required by 21 CFR 111.205(b)(2). In addition, your MMR for VitalErotic Shot failed to include the following information required by 21 CFR 111.210:
 
  • A statement of theoretical yield of a manufactured dietary supplement when you finished 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)];
  • 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)];];
  • Written instructions, including specifications for each point, step, or stage 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 MMR [21 CFR 111.210(h)(1);
  • Written instructions, including procedures for sampling and a cross-reference to procedures for tests and examinations [21 CFR 111.210(h)(2)]. 
 
We reviewed your written response received on January 16, 2013 and found it to be inadequate. You provided a revised document that includes packaging and labeling operations. However, you did not provide documentation showing that you implemented this corrective action. We note that your MMR must include all of the elements required by 21 CFR 111.210.
 
6.    Your batch production records (BPR) failed to include complete information relating to the production and control of each batch of your VitalErotic Shot product, as required by 21 CFR 111.255(b). The batch records that you provided to our investigator for all seven lots of VitalErotic Shot did not include documentation at the time of performance that quality control personnel approved and released, or rejected, the packaged and labeled finished dietary supplement as required by 21 CFR 111.260(l)(4). 
 
We reviewed your written response received on January 16, 2013 and found it to be inadequate. You provided a revised document thatincludes a signature section for the approval and release or rejection of finished, filled product. However, you did not provide documentation showing that you implemented this corrective action. We note that your BPR must contain all of the elements required by 21 CFR 111.260.   
 
This letter is not an all-inclusive list of violations at your facility.  It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations.
 
Failure to promptly correct the violations specified above may result in legal action without further notice, such as seizure and/or injunction.
 
We also have the following comment:
 
We note that there is a 3 year “best used by date” date placed on product labels of VitalErotic Shot products manufactured in your facility. During the inspection, you did not have any data supporting the “best used by dates” listed. Any expiration date, including a “best if used by date,” that you place on a product label should be supported by data that demonstrates the product’s shelf life (See 72 FR 34752 at 34856; June 25, 2007).
 
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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing as to the specific steps you have taken to correct the violations cited above, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions.  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.
 
Your written response to this letter should be sent to:
 
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
If you have any questions about the content of this letter, please contact Thao Kwan, Compliance Officer, at 949-608-4445 or Jessica Mu, Compliance Officer, at 949-608-4477.
 
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:      
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue - MS 7602
P.O. Box 997435
Sacramento, California 95899-7435
Attn: FDA Correspondence