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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Libi Labs, Inc. 3/13/14

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770

 

OVERNIGHT DELIVERY
VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-06
March 13, 2014
George L. Stuart, President
Libi Labs, Inc.
6901 Bryan Dairy Rd., Suite 130
Largo, FL 33777-1627
 
Dear Mr. Stuart:
 
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 6901 Brian Dairy Rd., Suite 130, Largo, FL 33777-1627, on March 25, 2013 through April 01, 2013. During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).  These violations cause your Green Coffee Bean Capsules and Weightloss Supplement Capsules dietary supplement products 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 dietary supplements have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements.
 
You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Dietary Supplement CGMP Violations
 
Your significant violations are as follows:
 
1.    You failed to 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).   
 
Specifically, you did not conduct any analysis to ensure the identity of any dietary ingredient prior to its use in manufacturing your dietary supplement products.  Your Director of Regulatory Affairs stated during the inspection that your firm currently does not have the financial resources to perform such testing. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition FDA under 21 CFR 111.75(a)(1)(ii) and FDA exempts you from such testing.  
 
We received your written response to the FDA 483, dated April 17, 2013, and your follow-up written response, dated July 17, 2013, and determined your responses to be inadequate. You state in your written response, dated April 17, 2013, that you have created SOP 2.1 - Format and Contents of Raw Material Specification Form, and that beginning May 1, 2013, all raw materials will be sent to an outside lab for testing.  However, the SOP attached with your written response is merely a procedure to define the format and contents of your raw material specification form and does not adequately document that you are conducting at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. You did not submit any documentation to show that you are now conducting at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in the manufacture of your dietary supplement products.
 
You state in your follow-up written response dated July 17, 2013, that “[t]he observed products are not manufactured after the inspection. All future orders of raw materials will be sent out for testing.” However, you did not submit any documentation to show that you are now conducting at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in the manufacture of your dietary supplement products. Your response, therefore, remains inadequate.
 
2.    You failed to qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of the supplier’s tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A), prior to relying on their COA to verify that applicable component specifications established in accordance with 21 CFR 111.70(b) are met.
 
Specifically, you failed to qualify a supplier of a component by establishing the reliability of the supplier’s COA through confirmation of the results of the supplier’s tests or examinations for the following components:
 
  • Green Coffee Bean Extract used in the manufacturing of Green Coffee Capsules product lot number HC-65.
  • Hard Gelatin Capsule Shells used in the manufacturing of Green Coffee Capsule product, lot number HC-65.
  • Green Tea Extract used in the manufacturing of Weightloss Supplement Capsules product lot number HC-17.
 
We received your written response, dated April 17, 2013, and your follow-up written response, dated July 17, 2013, and determined your responses to be inadequate. You state in your written response, dated April 17, 2013, that you sent letters to all of your suppliers indicating that they must comply with 21 CFR 111.75(a)(2)(ii)(A), (B), (C), (D), and (E). However, it is your responsibility to qualify a component supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A) and to otherwise satisfy the requirements of 21 CFR 111.75(a)(2)(ii).  We note that in order to confirm the identity of components that are not dietary ingredients and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, you must either conduct appropriate tests or examinations, or rely on a COA from the supplier of the component that you receive; however, in order to rely on a COA, you must first qualify the supplier of the COA by establishing the reliability of the supplier’s COA through confirmation of the results of the supplier’s tests or examinations, in addition to fulfilling the other requirements outlined in 21 CFR 111.75(a)(2)(ii). 
 
You state in your follow-up written response, dated July 17, 2013, that “supplier’s letters are attached.” As indicated in the preceding paragraph, the responsibility of qualifying your component suppliers lies with you, the manufacturer, rather than with your suppliers.
 
3.    You failed to establish component specifications for each component you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b).  Your Director of Regulatory Affairs stated during our inspection that your firm has not yet determined and established in writing any specifications for the components used to manufacture your dietary supplement products, including the Green Coffee Capsules and Weightloss Supplement Capsules. For example, you have not established an identity specification for your Green Coffee Bean extract component used to manufacture the Green Coffee Capsule product, Lot# HC-65.
 
We received your written response, dated April 17, 2013, and your follow-up written response, dated July 17, 2013, and determined your responses to be inadequate.  In your written response dated April 17, 2013, you stated that you have completed SOP 2.1 – Format and Contents of Raw Material Specification Form and that Raw Material Specification Forms have been prepared and you attached such documents to your written response. However, the Raw Material Specification Form for your Green Coffee Bean PE 4:1 component is inadequate. For example, the identification specification states “Conforms Positive”; this entry is not an adequate specification for identification because the entry does not specify to what the component conforms, or to what the term “positive” refers. Similarly, “C of A” appears to refer to a COA, but the COA was not provided with your written response.
 
4.    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).
 
Specifically, you failed to establish in-process specifications following the blending step to help ensure that specifications are met for the identity, strength, purity, and composition of your dietary supplement. For example, you do not have written in-process specifications for your blended Weightloss Supplement Capsules dietary supplement product.
 
We received your written response, dated April 17, 2013, and your follow-up written response, dated July 17, 2013, and determined your responses to be inadequate. You state in your written response, dated April 17, 2013, that you “are in the process of amending SOP’s and updating procedures with a target completion date of July 22, 2013” and that your employees will be trained on the updated SOP’s. Your follow up written response, dated July 17, 2013, states that your SOP, 4.13 Sampling for uniformity testing of powdered blend, was attached. However, your SOP 4.13 does not include the required in-process specifications for any point, step, or stage in your manufacturing process where control is necessary.
 
5.    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 do not have written MMRs covering the production of the following dietary supplement products:
 
  • Weightloss Supplement Capsules
 
-        Lot number HC-17, batch size (b)(4) containers of 90 capsules each, with 15% batch yield overage
-        Lot number HC-40, batch size of (b)(4) containers of 90 capsules each, with 15% batch yield overage
-        Lot number HC-73, batch size of (b)(4) containers of 90 capsules each, with 5% batch yield overage
 
  • Green Coffee Capsules
-        Lot number HB-39, batch size of (b)(4) containers of 90 capsules each, with 5% batch yield overage
-        Lot number HC-31, batch size of (b)(4) containers of 60 capsules each, with 15% batch yield overage
-        Lot number HC-65, batch size of (b)(4) containers of 60 capsules each, with 0% batch yield overage
 
We have received your written response, dated April 17, 2013 and your follow-up written response, dated July 17, 2013, and determined your responses to be inadequate. You state in your written response, dated April 17, 2013, that the Master Batch Records have been completed for Weightloss Supplement Capsules and Green Coffee Capsules and that they are attached to your written response.  However, the attached “Master Batch Records,” do not include the information required by 21 CFR 111.210. For example, the attached records do not include written instructions, as required by 21 CFR 111.210(h), including the following:
 
i.    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 master manufacturing record, as required by 21 CFR 111.210(h)(1);
ii.    Procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2);
iii.    Specific actions necessary to perform and verify 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 111.210(h)(3).
 
Your follow-up written response, dated July 17, 2013, did not contain additional information concerning this item.
 
The violations mentioned above are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
In addition to the violations discussed above, we have the following comment regarding your dietary supplements:
 
  • You informed our investigator that the “Expiration code [is] placed in ink on the bottom of the bottle.” Any expiration date, shelf life, or “Best by” date you place on a product label should be supported by stability data [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)]. The term ‘shelf life dating” includes expiration dating and “best if used by” dating [See 72 Fed. Reg. 34752, 34912 (Jun. 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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
 
For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
 
You should respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps that you are taking to correct the violations listed above and to prevent similar violations in the future. You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections. 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.
 
Please send your written reply to the Food and Drug Administration, Attention: Randall Morris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Mr. Morris at (407) 475-4741.
 
 
Sincerely,
/S/
Kathleen M. Sinninger
Acting Director, Florida District