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WARNING LETTER

Pure Herbs Ltd 02/04/2014

Pure Herbs Ltd - 04/02/2014


Recipient:
Pure Herbs Ltd


United States

Issuing Office:
Detroit District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2014-DET-08
 
April 2,  2014
 
VIA UPS
 
Mr. Eugene C. Watkins, President
Pure Herbs, Ltd.
33410 Sterling Ponds Boulevard
Sterling Heights, MI 48312
 
Dear Mr. Watkins,
 
The U.S. Food and Drug Administration (FDA) inspected your facility, located at 33410 Sterling Ponds Blvd., Sterling Heights, Michigan 48312, from April 23 through May 31, 2013. During the inspection, our investigator found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your 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 they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111. You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
 
Additionally, during the inspection our investigators collected and reviewed the labeling of your dietary supplement products. Based on our review of your product labeling, we have determined that your Ginkgo, Gotu Kola, and Chickweed dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101.
 
We received a response, dated June 19, 2013, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations.
 
Dietary Supplement CGMP Violations
 
The inspection and subsequent review revealed the following significant violations of the CGMP regulations for dietary supplements:
 
1.    You failed to establish component specifications for each component that you use in the manufacture of your dietary supplements, as required by 21 CFR 111.70(b). Specifically, your raw material product specification sheets for black cohost (root) and ashwagandha (root) list an identity specification of “[a]ppearance” and “[p]ositive ID” with methods of organoleptic and FTIR, respectively. However, these identity specifications are inadequate in that you did not characterize or provide the physical botanical characteristic and a voucher specimen or the referenced spectrum and how you characterize the reference standard to obtain the spectrum. 
 
We have reviewed your response dated June 19, 2013. You indicated that many of the “raw material products” your firm uses do not have standards. While we agree that having standards are necessary when determining whether your specifications are met, it is your responsibility to establish specifications for each component you use and to develop or purchase standards so that the test/exam you conducted can be compare to the data from the standards to determine if specifications are met. 
 
2.    Your firm failed to determine whether component specifications, which must be established in accordance with 21 CFR 111.70(b), are met prior to using them to manufacture dietary supplements, as required by 21 CFR 111.73. Specifically, you indicated to our investigator that your firm has not performed any testing on any lots of ethyl alcohol received from (b)(4) that you used in the manufacture of your herbal tincture dietary supplement products. 
 
We have reviewed your response dated June 19, 2013. You indicated that you will be “testing for identity, purity, strength, composition and limits of contamination, supported by certificates of analysis for the majority of products in all cases.” Your response is inadequate in that you did not provide any testing records to show you have implemented these procedures.
 
3.    Your firm failed to ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically: 
  • Black cohosh (Lot MB249) and ashwagandha (Lot MA183) "in-process” and “finished product testing" consist in part of some organoleptic analysis of appearance, color, odor, and taste. However, no reference standards were used to make any of these comparisons and no written acceptance criteria were provided to define any of these characteristics.
  • A sample of kelp and ashwagandha raw material (Lot 12L341-649) and (Lot #19040), respectively were tested for identification using FTIR by your contract laboratory on January 9, 2013, and September 19, 2012. The reference standards used to compare the spectra of these testing were a previous lot of kelp (Lot 11C080-649) and ashwagandha (Lot rmk0312700000) received from your supplier. There was no written acceptance criteria established for the passing identification test of kelp and ashwagandha. Spectra comparison of the tested material to the referenced spectra did not appear to match, however laboratory documentation states the identification of these tested samples passed.
Further, you failed to establish laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting reference materials used in performing tests and examination, as required by 21 CFR 111.315(d). Specifically, our review of your FTIR spectra testing record for the Kelp component (lot # 12L341-649) indicates that this lot was compare to a previous lot of the Kelp component as the referenced standard (lot #11C080-849). However, you failed to establish any criteria (i.e., characterization) of the kelp to establish a reference standard. Non-compendia reference standard materials should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength.
 
We have reviewed your response dated June 19, 2013. You indicated that your consultant was responsible for the testing methods to be scientifically valid methods and that the consultant has not “met this standard.” And, you also indicated that you will be determining specific scientific methods. Your response is inadequate because you did not provide any methods for review. 
 
4.    Your firm failed to establish product specifications for the identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of your finished dietary supplements, as required by 21 CFR 111.70(e). For example, our review of your finished product specification/testing document for the following finished batch of dietary supplements revealed that you did not establish these specifications:
  • Black Cohosh (Lot MB249) finished product specification sheet included specifications for appearance, pH, dissolved solids, specific gravity and loss on drying (LOD); however, these specifications do not address the required specifications for the identity, purity, strength and composition, and for the limits on those types of contamination that may adulterate or that may lead to adulteration of your finished dietary supplement.
  • Ashwagandha (Lot MA183) finished product testing document listed the following specifications that were tested: appearance, color, odor, specific gravity, pH, dissolved solids, and loss on drying (LOD); however, these specifications do not address the required specifications for the identity, purity, strength and composition, and for the limits on those types of contamination that may adulterate or that may lead to adulteration of your finished dietary supplement.
  • O.C.M. (Lot 021413) finished product testing document listed the following specifications to be tested: appearance, color, odor, specific gravity, pH, dissolved solids, and loss on drying (LOD); however, these specifications do not address the required specifications for the identity, purity, strength and composition, and for the limits on those types of contamination that may adulterate or that may lead to adulteration of your finished dietary supplement. 
We have reviewed your response dated June 19, 2013. You indicated that your internal quality control personnel will be working with an outside laboratory to address this issue. Your response is inadequate in that you did not provide any finished product specifications for these or any other dietary supplements products that meet the requirements under 21 CFR 111.70(e). 
 
5.    Your firm failed to examine a representative sample of each batch of the packaged and labeled dietary supplement, as required by 21 CFR 111.415(g), to determine whether it meets specifications for the packaging and labeling in accordance with 21 CFR 111.70(g). For example, there was no examination of the representative packaged and labeled dietary supplement to determine if packaging and labeling specifications were met prior to distribution for any of your firm’s products to include: 
  • Black Cohosh (Lot MB249A) bottled on March 21, 2013, and labeled on April 8, 2013.
  • Ashwagandba (Lot MA183A) bottled on April 12, 2013, and labeled on April 16, 2013.
  • O.C.M. (Lot 021413A) bottled on April 9, 2013, and labeled on April 10, 2013.
We have reviewed your response dated June 19, 2013. You indicated that you have changed your sampling plan to make sure that documented testing is done for raw material, in-process products and finished product testing after the product is bottled and labeled for each product manufactured. However, your response is inadequate in that you did not address whether you would collect and examine a representative sample of a packaged and labeled dietary supplement to determine if packaging and labeling specification were met prior to distribution. 
 
6.    Your Master Production Record (MPR) for your products Ginkgo and Black Cohosh failed to include written instructions of specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.210(h)(1).
 
Specifically, your MPR provided written manufacturing instructions, but those instructions failed to include such specifications as soaking/extraction time for your soaking/extraction process of various botanicals (i.e., ginkgo, black cohosh). 
 
We have reviewed your response dated June 19, 2013. You indicated that you had begun creating the master manufacturing records for each product in order to document the control and procedures. Your response is inadequate in that you have not demonstrated full compliance with meeting the required elements of your MMR. Specifically, we also reviewed your master production record in exhibit c of your response. This master production record failed to provide adequate written instructions in the use the hydrometer, including the specification for which the hydrometer is measuring in step FP-2. Further, there is no time specification on how long to stir the liquid in step IPT and no amount of liquid is specified to be drawn in step FF-1.
 
7.    Your firm does not use equipment that is of appropriate design, construction, and workmanship to enable them to be suitable for its intended use and to be adequately cleaned and properly maintained, as required by 21 CFR 111.27(a). Specifically, 4 blue, scored, pitted, and delaminating plastic drain barrels cut in half with holes drilled in the bottom of the barrels to facilitate draining were utilized to drain the herbal extract Buchu (Lot MA209) and several other herbal extracts to include: Knitbone, Protein, Royal Jelly, Whole Apricot, and Wild Rosehips.
 
Your firm’s response dated June 19, 2013, is not adequate as it did not include evidence that supports the acquisition and utilization of stainless steel drain drums.
 
8.    You failed to make and keep documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, as required by 21 CFR 111.35(b)(2). Specifically, there were no records to demonstrate that your X-1 press was cleaned after processing a major food allergen to prevent cross contamination into products manufactured after the allergen. For example: 
  • According to your squeeze log, on January 25, 2013, you squeezed (b)(4) gallons of Wheat Germ (Lot 032712), a major food allergen, on your (b)(4) press. You then squeezed Oatstraw and Alfalfa on the same day, but could not provide documentation that the press was cleaned prior to the next product squeeze.
  • According to your squeeze log, on January 18, 2013, you squeezed (b)(4) gallons of Black Walnut Hulls (Lot LJ199), a major food allergen, on your (b)(4) press. You then squeezed Rue, Slippery Elm Bark, and Uva Ursi on the following day, but could not provide documentation that the press was clean prior to the next product squeeze.
  • According to your squeeze log, on March 25, 2013, you squeezed (b)(4) gallons of Black Walnut Meats (Lot LG016), a major food allergen, on your (b)(4) press. You then squeezed Slippery Elm o the same day, but could not provide documentation that the press was clean prior to the next product squeeze.
In addition, you did not have documentation on the maintenance activities for your major processing equipment. On April 23, 2013, an employee was observed performing maintenance on your (b)(4) press by replacing the hydraulic fluid, but there was no record of this maintenance. 
 
We have reviewed your response dated June 19, 2013. You indicated you are keeping a cleaning and maintenance log since June 3, 2013. Your response is in adequate because you did not include documentation for our review that demonstrates that you made and kept documentation of maintenance, cleaning and sanitation for your (b)(4) press.
 
9.    Your firm’s quality control personnel did not approve the packaging and labels for use in the manufacture of a dietary supplement and release them from quarantine, as required by 21 CFR 111.160(c)(3). Specifically, from approximately January 1, 2013, to the time of our inspection, quality control personnel did not review labels received against any labeling specifications and release them from quarantine prior to their use in your labeling operation. During this time, labels were received by production personnel and placed directly in the label storage room where they were available for use in your dietary supplement labeling operation. For example, labels for Bee Propolis 4 oz., job # 630035, were received on approximately February 4, 2013, but were not quarantined. On April 9, 2013, 428 bottles of Bee Propolis 4 oz. (Lot MA187B) were labeled using labels that were not released from quarantine by your quality control personnel. There is no documentation that this review and approval of the labels were performed. 
 
Further, on approximately January 31, 2013, a shipment of 4 oz. bottles were received that included Lots 021760 and 025827. However, no quality control personnel evaluated any of these bottles against packaging specifications before they were use in your dietary supplement packaging operation. Specifically, bottles from Lot 021760 were used in bottling of Black Cohosh (Lot MB249A) on March 21, 2013, and bottles from Lot 025827 were used in bottling of O.C.M. (Lot 021413A) on April 9, 2013, before they were reviewed and approved for use. There is no documentation that these reviews and approvals of the packaging and labels were performed.
 
We have reviewed your response dated June 19, 2013. Your response indicates that you are in the process of writing a SOP for the order, approval and release of labels, but that procedures are being followed since June 7, 2013. Your response is inadequate in that you did not provide the SOP for our review and include documentation that demonstrates that you are implementing these procedures. 
 
10.    You did not make and keep a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2). Specifically, you received at least one complaint regarding your ginkgo product (lot 242) that alleged the product was water.   However, there was no written record that this complaint was reviewed, investigated, and followed-up on by your firm. 
 
We have reviewed your response dated June 19, 2013. You indicated that your SOP regarding product complaints was revised and that the necessary employees were trained on June 10, 2013, for the proper identification, handling, disposition and investigation of each complaint. Your response is inadequate in that you did not include your revised SOP for review and provide documentation that showed your implementation of the procedures. 
 
11.    Your firm failed to identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision, as required by 21 CFR 111.510. For example, in your bottling room, FDA investigators observed several shelves of returned dietary supplements to include 4 oz. bottles of Olive Leaf (Lot L1172A), Angelica (Lot 082109), and O.C.M. (Lot 081412A) that were not identified or quarantined. The shelves containing the returned supplements were not spatially segregated and were located on the same row, directly adjacent to shelves containing in-process and finished products that were ready for distribution.  Additionally, there was no documentation to support that quality control personnel conduct material reviews for returned products.
 
Your firm’s response dated June 19, 2013, is not adequate as it did not include documentation that demonstrates revision and implementation of your returned dietary supplement procedure.
 
12.    You firm failed to make and keep documentation of training including the date of the training, the type of training, and the persons trained, as required by 21 CFR 111.14(b)(2). Specifically, our investigator reviewed your Standard Operating Procedure (SOP) binder for training, but no training procedures were found in the binder for review. 
 
Your firm’s response dated June 19, 2013, is not adequate as it did not include training documentation used to train your employees.
 
Misbranded Dietary Supplements
 
Your Ginkgo, Gotu Kola, and Chickweed products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the labels fail to identify the products using the term “dietary supplement” as required by 21 CFR 101.3(g).
 
Your Ginkgo, Gotu Kola, and Chickweed products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the labels failed to bear nutrition labeling (“Supplement Facts” panel), as required by 21 CFR 101.36.
 
Your Ginkgo, Gout Kola, and Chickweed products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761(b) of the Act [21 U.S.C. § 379aa-1(b)], may receive a report of a serious adverse event associated with the product.
 
Your Ginkgo, Gotu Kola, and Chickweed products are misbranded within the meaning of section 403(i)(2) in that they are fabricated from two or more ingredients, but the label fails to list the non-dietary ingredients (e.g., neutral grain spirits (38%), distilled water) immediately below the nutrition label, as required by 21 CFR 101.4(g).
 
The above is not intended to be an all-inclusive list of violations in connection with your dietary supplement products. You should take prompt action to correct all violations.  It is your responsibility to assure your firm complies with all requirements of the Act and FDA regulations.  Failure to promptly correct these violations may result in legal action without further notice, including seizure and injunction.  
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above.  You may 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 when you will complete the corrections. Please send your reply to the Food and Drug Administration, Attention: CDR Kimberly Martin, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207.
 
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 noncompliance materially related to a food safety requirement of the FD&C 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 noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
If you have questions regarding any issues in this letter, please contact CDR Martin at 317-226-6500 ext. 116.
 
Sincerely,
/S/ 
Glenn T. Bass
District Director
Detroit District Office