- Delivery Method:
- Certified Mail
- Food & Beverages
Recipient NameRhonda H. Summerland
- Western Herb Products, Inc.
P.O. Box 115
Index, WA 98256
- Issuing Office:
- Office of Human and Animal Food Operations – West Division 6
December 7, 2021
In reply, refer to CMS 615439
Dear Dr. Summerland:
The United States Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 21624 Sertz Road, Index, Washington, on May 3, 4, and 12, 2021. During the inspection, we identified serious violations of Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause the dietary supplement products manufactured at your facility 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 (U.S.C.) § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. In addition, the Wormwood/Aloes dietary supplement product that you manufacture is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You can find the Act and FDA regulations through links in FDA's home page at www.fda.gov.
We received an e-mail correspondence from you dated May 31, 2021, written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We address your response below, in relation to each of the noted violations.
Dietary Supplement CGMP Violations
Your significant violations of CGMP requirements are as follows:
1. You failed to establish the 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 (MMR), as required by 21 CFR 111.70(a). You do not have written specifications to ensure the consistent production of your finished dietary supplements. Specifically, for your Wormwood/Aloes dietary supplement capsules, lot #06821-6:
a. For your components:
i. You failed to establish an identity specification, as required in 21 CFR 111.70(b)(1).
ii. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplement manufactured using the components are met, as required in 21 CFR 111.70(b)(2).
iii. You failed to establish 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, as required in 21 CFR 111.70(b)(3).
b. You failed to establish in-process specifications for any point, step, or stage in the MMR where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplement, as required by 21 CFR 111.70(c)(1). Included in the manufacture of the Wormwood/Aloes dietary supplement is the (b)(4) and (b)(4) of the wormwood powder and aloe powder. A (b)(4) inspection is performed on the herb(s) after (b)(4) the blend of wormwood powder and aloe powder; however, an acceptance criterion related to the (b)(4) of the (b)(4) blend (e.g., (b)(4)) does not ensure that specifications are met for the composition of the dietary supplement.
c. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants 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 received and reviewed your revised specification sheets for the dietary ingredients, wormwood and aloe, and for the Wormwood/Aloes dietary supplement submitted with your May 31, 2021, written response to the inspection and have the following comments:
The specifications were revised to include identification by microscopic examination with an acceptance criterion of “(b)(4),” and the purity strength specification states “(b)(4).” The identity specification is inadequate in that the microscopic specification fails to include characteristics that will allow you to confirm the identity of the ingredient at issue, such as specific microscopic characteristics that should be observed for comparison to the standard. We are also unable to evaluate the sufficiency of your “Purity/Strength” standard on your revised specification sheet, which states, “(b)(4),” as this specification does not provide the specific portion or percentage that is wormwood or aloe powder, nor does it provide the specific concentration that is expected for each of the powders. The documentation you provided fails to provide a specification for composition for the individual wormwood powder and aloe powder.
Further, you included microscopic examination in your revised specification sheets in addition to organoleptic and macroscopic methods to identify the botanical powder and provided photos of two products showing a comparison of their physical structures under the microscope at different forms (whole leaf, rough cut, and finer cut). Microscopic analyses may be an appropriate identity test for whole or coarsely cut botanical parts, but it may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur [Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 72 Fed. Reg. 34752, 34852 (June 25, 2007)]. The physical characteristic of a plant significantly decreases as the plant is cut into a finer size or powder, as evidenced in the photos you provided.
Your component and finished product specifications regarding limits of contamination are inadequate because you did not specify which heavy metals are subject to the specification (component) or are not established (finished product).
Your finished product specification is further inadequate in that identity cannot be determined by verification of input as it does not provide a specific physical or qualitative property that can be used to confirm identity, nor does it include a numeric or quantitative limit for comparison; purity as a function of no additives or flow agents does not provide the specific portion or percentage that is wormwood and aloe powders; strength as an amount of dietary ingredient cannot be adequately evaluated because the method by which the strength can be verified was not provided; and composition as a statement of a blend of OG Wormwood (Artemisia absinthium) leaf and cape aloes (Aloes ferox) leaf powders in “00” gelatin capsules does not provide the percent of wormwood and aloe powders comprised in the blend.
Further, you have not established specifications for the empty hard-shell gelatin capsule #00 ((b)(4)) used in the manufacture of your dietary supplement capsules.
Finally, you provided a label proof that includes specifications (e.g., die number, dimensions stock, and unwind directions). To the extent that you intend to use the label proof to satisfy the requirement for label specifications under 21 CFR 111.70(d), we note that it is unclear if this is the label used in all labeling operations or if the specifications provided are the official labels. Furthermore, the label proof does not have approval by your quality unit documented on the record.
Moreover, your response dated May 31, 2021, did not include any interim corrective action to ensure that the dietary supplements that you manufacture and distribute are what they purport to be and are free from contamination. Although you stated during the inspection that it would take approximately six months to complete the majority of your product specifications, and longer than six months for those products that you order only once or twice a year, you did not provide additional information about this timeline in your response or explain why it would take six months, nor did you specify corrections that you would make in the meantime.
Once you have established the specifications identified above, you must verify that the specifications are met in accordance with 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records of the specifications established in accordance with 21 CFR 111.95(b)(1). Your Quality Control Personnel must approve specifications, among other things, as required by 21 CFR 111.105(a).
2. You failed to prepare and follow a 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, which includes all required information, as required by 21 CFR 111.205(a) and 21 CFR 111.210. Specifically, during the inspection, when the FDA investigator requested information about your MMRs, you provided a document titled “Master Manufacturing Record,” dated March 8, 2021, for the manufacture of the Wormwood/Aloes dietary supplement. The document lacked the following information that must be included in an MMR, as required in 21 CFR 111.210:
a. The strength and concentration of each dietary ingredient for each batch size [21 CFR 111.210(a)];
b. A complete list of components to be used [21 CFR 111.210(b)];
c. An accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)];
d. The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)];
e. A statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)];
f. A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish 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)];
g. 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)]; and
h. The following written instructions:
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 MMR [21 CFR 111.210(h)(1)];
ii. Procedures for sampling and a cross reference to procedures for tests or examinations [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 [21 CFR 111.210(h)(3)]; and
iv. Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
We received your revised MMRs submitted with your May 31, 2021, written response to the inspection. Our review of these documents indicates they are inadequate because they continue to lack the required information for an MMR as listed above.
3. You failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplement, which includes all required information, as required by 21 CFR 111.255(a) and 21 CFR 111.260. Specifically, the BPR you provided for your Wormwood/Aloes dietary supplement lacked the following information that must be included in a BPR, as required by 21 CFR 111.260:
a. The identity of equipment used in producing the batch [21 CFR 111.260(b)];
b. The date and time of the maintenance, cleaning, and sanitizing of the equipment used in producing the batch, or a cross-reference to records, such as individual equipment logs where the information is retained [21 CFR 111.260(c)];
c. The identity and weight or measure of each component used [21 CFR 111.260(e)];
d. A statement of the actual yield and a statement of the percentage of theoretical yield at the appropriate phases of processing [21 CFR 111.260(f)];
e. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
f. Documentation that the finished dietary supplement meets specifications for identity, purity, strength, composition, and limits on contamination and for packaging and labeling [21 CFR 111.260(i)];
g. Documentation, at the time of performance, of the manufacture of the batch, including the date on which each step of the master manufacturing record was performed and the initials of the persons performing each step [21 CFR 111.260(j)(1)];
h. Documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for weighing or measuring each component used in the batch, the person responsible for verifying the weight or measure, the person responsible for adding the component to the batch, and the person responsible for verifying the addition of components [21 CFR 111.260(j)(2)];
i. Documentation, at the time of performance, of packaging and labeling operations, including the unique identifier you assigned to packaging and labels used, an actual or representative label of the finished product as specified in the master manufacturing record, and the results of any tests or examinations conducted on packaged and labeled dietary supplements [21 CFR 111.260(k)]; and
j. Documentation, at the time of performance, that the quality control personnel reviewed the batch production record, approved, or rejected any reprocessing or repackaging, approved, and released the batch or rejected the batch for distribution, and approved and released or rejected the packaged and labeled dietary supplement [21 CFR 111.260(l)].
We are unable to adequately assess your corrective action submitted in your May 31, 2021, response for this observation because you did not provide documentation for review that demonstrates you are preparing a BPR that includes all required information for every manufactured batch of dietary supplement.
4. You 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, and for approving or rejecting any processing, as required by 21 CFR 111.103. Specifically, you have no written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any processing.
Once you have established your quality control written procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65.
We have reviewed your revised Standard Operating Procedures (SOPs) submitted with your May 31, 2021, written response. Section IV Quality Control/QA of your SOP includes the duties of quality control, duties of quality assurance, and inspection of materials. However, it does not include written procedures documenting how you conduct a material review, make a disposition decision, and approve or reject any reprocessing related to ingredients, in-process material, finished products, and packaging and labeling components.
5. You failed to establish and follow written procedures to fulfill the requirements for product complaints, as required by 21 CFR 111.553. Specifically, you have no written procedures for product complaints.
We have reviewed your revised SOPs submitted with your May 31, 2021, written response. Section I Materials of your SOP includes a subsection on product returns which describes your complaint procedure. It states that complaints are addressed on an individual basis, and if a concern about a specific lot of herbs is warranted, customers who received the lot are notified as noted in your recall plan. Your written procedure is inadequate in that it does not provide sufficient information to determine whether a qualified person will review and investigate product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; whether quality control personnel will review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed; and whether the required review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and follow-up action of any investigation performed, must extend to all relevant batches and records, as required by 21 CFR 111.553 and 21 CFR 111.560.
Note that after you have established such procedures, you must make and keep a written record of every product complaint, as required by 21 CFR 111.570(b)(2).
Misbranded Dietary Supplements
6. Your Wormwood/Aloes dietary supplement is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the labels fails to identify the appropriate part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example:
a. The label indicated that Artemisia absinthium is derived from the leaf part of the plant, however, the specification sheet indicated that the botanical ingredient is derived from the aerial parts, which include the entire plant parts that grow above the ground.
b. The label indicated that Aloe ferox is derived from the leaf part of the plant, however, the supplier specification sheet indicated it is derived from the juice or resin from leaves.
The plant part declared on the product label must be consistent with the actual plant part identity as indicated on the specification sheet.
7. Your Wormwood/Aloes product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.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. For example:
a. The title, "Supplement Facts," is not larger than all other print in the panel [21 CFR 101.36(e)(1)];
b. The title and all headings are not bolded to distinguish them from the other information [21 CFR 101.36(e)(1)];
c. The Serving Size is not placed under the "Supplement Facts" heading and not aligned on the left side of the nutrition label [21 CFR 101.36(b)(1)]; and
d. There are no spaces between text lines and the letters within the panel touch one another and, in general, the label is not offset from the remainder of the label in a box and does not have the bolding, heavy bars, etc. [21 CFR 101.36(e)].
8. Your Wormwood/Aloes product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, Artemisia absinthium and Aloe ferox are not the standardized common names for these dietary ingredients. Furthermore, the product specification sheet and master manufacturing records indicate the product’s dietary ingredients are powdered extracts, but the product label fails to state the dietary ingredients are extracts.
9. Your Wormwood/Aloes product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7. Specifically, your label states that “This package contains approximately” 300 “00” capsules. “Approximately” is not provided for in 21 CFR 101.7.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Jinkee M. Vila-Binayug, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Vila-Binayug at 425-302-0413.
Miriam R. Burbach
Program Division Director
Office of Human and Animal Food
Operations – West Division 6