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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Big Easy Confections, L.L.C. 8/14/14

  

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

Public Health Service
Food and Drug Administration
 New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
 
Telephone: (615) 366-7801
FAX:   (615) 366-7802

 

August 14, 2014
WARNING LETTER NO. 2014-NOL-18
  
FEDERAL EXPRESS
DELIVERY SIGNATURE REQUESTED
 
Jarreth K. Wheeler, Co-Owner
Big Easy Confections, LLC
74034 Highway 1077, Suite 2
Covington, Louisiana 70435-0701
 
Dear Mr. Wheeler:
 
On May 5-14, 2014, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility located at 74034 Highway 1077, Suite 2, Covington, Louisiana. During the inspection, our investigator found a number of serious 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 111).  These violations cause dietary supplement products manufactured by your firm, including “(b)(4)” to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements.
 
Additionally, our investigator collected and reviewed your product label for the dietary supplement product, “(b)(4)” during the inspection of your facility.  Based on our review of your product label, we have determined your “(b)(4)” dietary supplement is misbranded within the meaning of Section 403 of the Act [21 USC 343] because it does not comply with FDA’s labeling regulations under 21 CFR 101.  You may find the Act and FDA’s regulations through links on FDA’s Internet home page at www.fda.gov.
 
We acknowledge receipt of your response, dated May 27, 2014, and address it below.
 
Dietary Supplement CGMP Violations
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements:
 
1.    Your firm 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) unless FDA grants an exemption under 21 CFR 111.75(a)(1)(ii). Specifically, you accept and use components based on a certificate of analysis (COA) from the supplier without performing any identity tests. 
 
Your response indicated you are now sending the supplier’s COA to your laboratory for confirmation, and you have established a SOP to qualify your suppliers. However, your response is inadequate. As explained above, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you are granted an exemption by FDA.  You cannot rely on a COA to verify the identity of a component that is a dietary ingredient. You failed to provide supporting documentation of any correction and established procedures.
 
2.    Your firm failed to qualify suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). 
 
Your response indicated you are now sending the suppliers’ COAs to your laboratory for confirmation, and that you have established an SOP to qualify your suppliers. However, your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
3.    Your firm 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 and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). Specifically,
 
  • You failed to establish specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement, as required by 21 CFR 111.70(e).
  • You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specification which ensure you used the specified packaging and you applied the specified label, as required by 21 CFR 111.70(g).
 
Once you have established the above specifications, you must determine whether the established specifications are met in accordance with 21 CFR111.73, and you must make and keep records in accordance with 21 CFR 111.95(b).
 
Your response indicated you have established specifications for each component and finished product.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established specifications.
 
4.    Your firm failed to prepare and follow a written master manufacturing record (MMR) for each batch size of the dietary supplement that you manufacture, to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a).
 
Your response indicated you have created a “master batch record” for all products and that you have established an SOP on verifying, dating, and keeping the MMR. However, your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
5.    Your firm failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255(a). Specifically, during the inspection you stated you do not document your manufacturing operations.
 
Your response received indicated you have established an SOP for creating a batch and filling out batch production records.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
6.    Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Additionally, you stated that you maintain quality control by examining product and verifying with an independent lab to ensure your products are manufactured within specifications; however, you failed to keep written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements, in accordance with 21 CFR 111.140(b)(2).
 
Your response indicated you have hired a full time quality control director and that he has established written procedures for quality control.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established quality control procedures.
 
7.    Your firm failed to quarantine components before you use them in the manufacture of a dietary supplement, as required by 21 CFR 111.155(c).  Specifically, you did not quarantine prior to release by quality control each lot of components.  All materials received are used without further review.
 
Your response indicated you have established written procedures for sampling, quarantine, and approving each lot.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
8.    Your firm failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403.
 
Your response indicated you have established written procedures for identifying and applying the correct label.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
9.    Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.
 
Your response indicated you have established written procedures for holding and distribution operations.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established holding and distributing procedures.
 
10.    Your firm failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503.
 
Your response indicated you have established written procedures for handling product returns.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established returned products procedures.
 
11.    Your firm failed to establish written procedures for fulfilling the requirements for the review and investigation of product complaints, as required by 21 CFR 111.553.
 
Your response indicated you have established written procedures for handling complaints.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established complaints procedures.
 
12.    Your firm failed to establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a).  Furthermore, you failed to make and keep records of any calibrations, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(3).  Specifically, you do not have records for the calibration of scales and pH meters used during the manufacturing of your dietary supplement product.
 
Your response indicated you have established written procedures and records for calibration of all equipment.  However, your response is inadequate because you failed to provide supporting documentation of your corrections and established calibrations procedures.
 
Misbranded Dietary Supplements
 
Your “(b)(4)” product is misbranded under Section 403(y) of the Act [21 USC 343(y)] because the label fails to include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement, as described in Section 761 of the Act [21 USC 379aa-1].
 
Further, your “(b)(4)” product is misbranded under Section 403 of the Act [21 USC 343] because it does not comply with the FDA’s labeling regulations under 21 CFR 101:
 
1.    Your “(b)(4)” product is misbranded under 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 “(b)(4)” product is misbranded within the meaning of Section 403(e)(1) of the Act [21 USC 343(e)(1)] because the product label does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product.  It is your responsibility to ensure that all of your products are in compliance with 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/or injunction.
 
In addition to the above violations, we also have the following comment:
 
You stated to our investigator you assign 12 month “best by” date from the month of production to each batch of “(b)(4)” manufactured. Please note any expiration date, shelf life, shelf life dating 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. 34912, 34855 (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 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 of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations noted above.  Your response should include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation that would assist us in evaluating your corrections.  If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time in which you will complete the correction.
 
Please send your reply to Kari L. Batey, Compliance Officer, United States Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.
 
Sincerely,
/S/ 
Ruth P. Dixon
Acting District Director
New Orleans District
 
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