WARNING LETTER
NatureLab Corp.
MARCS-CMS 625768 —
July 12, 2022
Delivery Method:
Via Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
Charles B. Shea
Recipient Title
President
NatureLab Corp.
1606 Vantage Dr.
Carrollton
,
TX
75006-5613
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
July 12, 2022
WARNING LETTER
CMS #625768
Dear Mr. Shea:
The United States Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 1606 Vantage Dr., Carrollton, TX 75006-5613 on October 18-22, 2021, conducted as a follow-up to an inspection conducted at your facility April 8-May 6, 2021, and a meeting held with you on August 6, 2021. During the inspection, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. You can find the Act and FDA regulations through links in FDA's home page at
www.fda.gov.
We received e-mail correspondences from you dated November 16 and December 9, 2021, written in response to the Form FDA 483 Inspectional Observations issued to you at the close of the inspection. We address your responses below, in relation to each of the noted violations.
Adulterated Dietary Supplements
The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
The violations include the following:
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
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
, and
(b)(4)
products:
a. For the components you use in the manufacture of your dietary supplements, you failed to establish:
1. An identity specification, as required in 21 CFR 111.70(b)(1).
2. 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).
3. 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).
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 contamination 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 responses, dated November 16 and December 9, 2021. These responses included a “Certificate of Quality” for
(b)(4)
. In your responses, you stated that this
(b)(4)
“spec sheet” specifies the data tested from the third-party testing lab
(b)(6)
qualitative and quantitative analysis, but you did not provide any supporting documentation regarding these analyses or any information providing the basis on which these analyses could be used to establish product specifications. For example, the analytical methods used were not provided, and the specification of “POSITIVE” provides no information on which we can evaluate the scientific validity of the methodology used for your purported identity specification. Further, your responses do not address any of the
(b)(4)
dietary supplement products manufactured by your facility that were reviewed by the investigators during the inspection and identified as not having finished product specifications established 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 MMR.
Once you have established specifications, you must determine whether the specifications are met in accordance with 21 CFR 111.73 and 21 CFR 111.75. You must also ensure any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of all activities relating to such specifications in accordance with 21 CFR 111.95(b).
Related to your responses of November 16 and December 9, 2021, we also note that your responses indicate you will verify finished product specifications by monitoring “various steps” in the manufacturing process. Even if your established specifications were adequate, this method of confirming that such specifications have been met is an inadequate method for determining if finished product specifications have been met. You have not identified a method on how to determine product specifications.
2. You failed to prepare and follow an 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, when we requested your MMRs during the inspection, your firm could not provide a complete, written MMR for each dietary supplement for every batch size for the following dietary supplements:
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
, and
(b)(4)
. The documents provided as MMRs lacked the following required information:
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)];
iv. Special notations and precautions to be followed [21 CFR 111.210(h)(4)]; and
v. Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
We received and reviewed your responses, dated November 16 and December 9, 2021. Your responses included the documents “MMR-1-
(b)(4)
,” “MMR-2-
(b)(4)
,” and “MMR –
(b)(4)
(observ 4),” submitted as examples of your revised MMR’s. The MMRs provided fail to demonstrate the sufficiency of your corrective action because they do not meet the above-listed requirements of 21 CFR 111.210. In addition, you did not provide MMRs for the
(b)(4)
products reviewed during the inspection and identified on the FDA 483 as lacking MMR’s (
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
, and
(b)(4)
).
3. Your batch production record (BPR) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, when we requested your BPRs during the inspection, your firm could not provide a complete, written BPR for the following dietary supplements:
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
, and
(b)(4)
. The documents provided as BPRs lacked the following required information:
a. The identity of equipment and processing lines 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 unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)];
d. The identity and weight or measure of each component used [21 CFR 111.260(e)];
e. 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)];
f. The actual results obtained during any monitoring operation [21 CFR 111.260(g)]
g. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
h. 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)];
i. 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)];
j. Documentation, at the time of performance, of packaging and labeling operations, including the unique identifier you assigned to packaging and labels used, the quantity of the packaging and labels used, and when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR; and the results of any tests or examinations conducted on packaged and labeled dietary supplements, or a cross-reference to the physical location of such results [21 CFR 111.260(k)];
k. Documentation, at the time of performance, that the quality control personnel reviewed the BPR; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution; and approved and released, or rejected, the packaged and labeled dietary supplement [21 CFR 111.260(l)];
l. Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)]; and
m. Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].
We received and reviewed your responses, dated November 16 and December 9, 2021. Your responses included examples of BPR’s and “Sub-BPR’s”. The responses fail to demonstrate the sufficiency of your corrective action because the documents provided fail to include all required information under 21 CFR 111.260, and they fail to provide any information pertaining to the
(b)(4)
products reviewed during the inspection and identified on the FDA 483 as lacking BPR’s (
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
, and
(b)(4)
).
4. You failed to examine, before packaging and labeling operations, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the master manufacturing record, as required by 21 CFR 111.410(c). Specifically, your firm’s MMR did not include all ingredients listed on the finished product label, and product is released as such.
5. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, your firm management stated during the inspection that your firm does not record or track complaints in an official manner, and your standard operating procedures have no procedure for handling complaints.
You must ensure product complaints are reviewed and investigated, as required by 21 CFR 111.560, and that written records of your written procedures for products complaints and every product complaint related to good manufacturing practice are made and kept, as required by 21 CFR 111.570.
We received and reviewed your responses, dated November 16 and December 9, 2021. Your responses included the documents “Complaint Log Physical observation 11” and “ComplaintLogDigital observation 11,” which consist of photos of a physical file folder named “Complaint Log 2021” and a digital file folder, respectively. The responses fail to demonstrate the sufficiency of your corrective action because you did not provide any supporting documentation to show that your complaint procedures have been implemented.
Misbranding Violations
1. The “
(b)(4)
,” “
(b)(4)
,” and “
(b)(4)
” products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example:
The directions of use for the “
(b)(4)
” and “
(b)(4)
” products suggest the consumer take “4” capsules daily, “2” capsules in the morning and “2” capsules in the afternoon; in this case, the serving size should be two capsules.
The directions for use for the “
(b)(4)
” product suggest the consumer take “3-5” capsules per day split between meals. The serving size listed should be specific to what is to be consumed in a single eating occasion. You provide an example of consuming one capsule with lunch and two capsules with dinner. In this example, the serving size should be two capsules.
2. The product “
(b)(4)
” and “
(b)(4)
” products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because each label fails to declare the correct number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii). The number of servings must be calculated from the serving size, that being the maximum amount per eating occasion, and the total contents of the package.
3. The
(b)(4)
product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because it does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
4. The
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
,
(b)(4)
and
(b)(4)
products are each 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 the product does not comply with 21 CFR 101.36. For example:
a. The
(b)(4)
,
(b)(4)
, and
(b)(4)
products declared (b)(2)-dietary ingredients and other dietary ingredients on each Supplement Facts label are not provided in the order and format prescribed in 21 CFR 101.36 which requires the (b)(2)-ingredients to be listed first followed by a heavy bar and then other dietary ingredients.
b. The
(b)(4)
and
(b)(4)
product labels each bear the following statement: “Percent Daily Values based on a 2,000-calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
c. The
(b)(4)
Supplement Facts label declares incorrect % DVs for thiamine, Vitamin B6 and Vitamin B12; likewise, % DV for thiamine in the
(b)(4)
product does not appear to be rounded to the nearest whole percent. Furthermore, the quantitative amount of thiamine should be rounded to the nearest tenth of a milligram. For both products, the listing of “DV%” is incorrect but may be listed as “% DV”. Finally, the “%” symbol must follow each numerical value listed as a DV.
d. The
(b)(4)
Supplement Facts label should use the term “mcg” instead of “ug” as the unit of measure for the Vitamin B12.
e. The
(b)(4)
Supplement Facts label incorrectly declares as a (b)(2)-dietary ingredient, “Vitamin K (as menaquinone-7)”. 21 CFR 101.9(c)(8)(iv) lists an RDI for vitamin K of 120 mcg based
on the AI (adequate intake) that pertains only to phylloquinone. Menaquinone-7 should be listed as a (b)(3)-dietary ingredient.
f. The
(b)(4)
and
(b)(4)
Supplement Facts labels incorrectly list potassium chloride, potassium citrate, or calcium bisglycinate, as a (b)(3)-dietary ingredients. Potassium, chloride, and calcium are each a (b)(2)-dietary ingredient and must be listed with the other (b)(2)-dietary ingredients if the quantitative amount by weight per serving) is at least 2% of the RDI.
g. The
(b)(4)
product label fails to place the “Other Ingredients” list below the Supplement Facts label.
h. The
(b)(4)
Supplement Facts label incorrectly declares % DV for Total Sugars when then there is no DV for Total Sugars. The Supplement Facts label lists sodium and cholesterol in amounts that can be declared as zero. Any (b)(2)-dietary ingredients not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared in accordance with 21 CFR 101.36(b)(2)(i).
i. The
(b)(4)
Supplement Facts label incorrectly lists “0% DV” for the Total Carbohydrate. Per 21 CFR 101.36(b)(2)(iii)(C), the % DV should be declared as “Less than 1%” or “< 1%” for the % DV. In addition, calories per serving are incorrectly listed; calories must be expressed to the nearest 5-calorie increment up to and including 50 calories, per 21 CFR 101.9(c)(1).
5. The
(b)(4)
and
(b)(4)
products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each 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,
a. The
(b)(4)
label fails to declare the standardized common name of “tragacanth milkvetch” for the declared dietary ingredient “Astragalus gummifer”, as listed in the reference
(b)(4)
.
b. The
(b)(4)
label fails to declare the standardized common name of uva-ursi for the declared dietary ingredient “Arctostaphylos uva-ursi (Bearberry; leaf), as listed in the reference
(b)(4)
.
6. The
(b)(4)
and
(b)(4)
products are each misbranded in that the FDA disclaimer declared on each product label is not in accordance with 21 CFR 101.93(c).
7. The
(b)(4)
and
(b)(4)
products are each misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that each product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
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.
Your written response should be sent to Rene R. Ramirez, Compliance Officer, U.S. Food and Drug Administration, 1201 North Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Ramirez at rene.ramirez@fda.hhs.gov or (210) 308-1425.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
Content current as of:
11/08/2022
Regulated Product(s)
Dietary Supplements