WARNING LETTER
West Coast Laboratories, Inc.
MARCS-CMS 672954 —
June 12, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
Recipient Name
Robert P. Bailly
Recipient Title
Acting CEO
West Coast Laboratories, Inc.
116 E. Alondra Blvd.
Gardena
,
CA
90248-2806
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
June 12, 2024
WL 672954
Dear Mr. Bailly:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 116 E. Alondra Blvd., Gardena, CA from October 3 through October 24, 2023. Based on the inspectional findings we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection on October 24, 2023, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your written responses dated November 15, December 1, and December 7, 2023. Your November 15 and December 1, 2023, communications did not address the specific observations. We address your December 7, 2023, response below, where relevant.
Adulterated Dietary Supplements
The inspection of your facility from October 3, 2023, through October 24, 2023, identified serious violations of 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 the Calcium Pyruvate, Chromium Picolinate, and CalComplex products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 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.
Your significant violations of the CGMP requirements are as follows:
1. You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i), nor did you petition the agency under 21 CFR 111.75(a)(1)(ii) for exemption from such testing.
Specifically, you did not conduct identity testing for
(b)(4)
Lot
(b)(4)
, Naticol HPMG Lot
(b)(4)
, and Aquamin F
(b)(4)
used in the manufacture of CalComplex Lot 523008; you did not conduct identity testing for
(b)(4)
Lot
(b)(4)
used in the manufacture of Chromium Picolinate Lot 40223; nor did you conduct identity testing for Calcium Pyruvate Lots
(b)(4)
or Lot
(b)(4)
used in the manufacture of Calcium Pyruvate Lot 150822. You also have not petitioned the agency for an exemption for such testing.
We have reviewed your response dated December 7 ,2023, in which you provided revised raw material specifications for Aquamin F, Calcium Pyruvate,
(b)(4)
, and Naticol HPMG. Each of these documents purports to establish a specification of more than
(b)(4)
match by FTIR. However, you did not provide test records to support that you are conducting identity testing in accordance with the established identity specifications for each of these components.
2. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically:
a. For
(b)(4)
you do not have specifications to ensure the purity, strength, and composition of the
(b)(4)
and
(b)(4)
used in the manufacture of CalComplex.
b. For Naticol HPMG you do not have specifications to ensure the purity, strength, and composition of proteins used in the manufacture of CalComplex.
c. For Aquamin F you do not have specifications to ensure the purity, strength, and composition of
(b)(4)
used in the manufacture of CalComplex.
d. For
(b)(4)
you do not have specifications to ensure the purity, strength, and composition of
(b)(4)
used in the Chromium Picolinate dietary supplement.
e. For Calcium Pyruvate you do not have specifications to ensure the purity, strength, and composition of
(b)(4)
used in the manufacture of Calcium Pyruvate.
In addition to establishing these specifications, you must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 111.75.
We have reviewed your response dated December 7 ,2023, which included revised specifications for the ingredients Calcium Pyruvate,
(b)(4)
; and finished product specifications for Chromium Picolinate, CalComplex, and Calcium Pyruvate. Your revised specifications do not meet the requirements of 21 CFR 111.70(b)(2) in that they do not include appropriate specifications to ensure the purity and composition of Chromium Picolinate, Calcium Pyruvate and CalComplex.
3. Your quality control approved and released for distribution a batch of dietary supplement for which a component in the batch did not meet its identity specification, as required by 21 CFR 111.123(b)(1). Specifically,
(b)(4)
Analytical/Chemical Certificate of Analysis dated 9/23/22 for Calcium Pyruvate Lot
(b)(4)
includes an out-of-specification result of
(b)(4)
for Calcium. The specification is
(b)(4)
. The ingredient was used in the manufacture of Calcium Pyruvate Lot 150822 on 9/9/22, which was prior to testing. Your quality control approved and released the batch on 10/21/22.
4. Your quality control operations failed to approve and release all components from quarantine before they are used in the manufacture of a dietary supplement, as required by 21 CFR 111.120(e). Specifically, you used the following components in manufacture before your quality control personnel approved and released them from quarantine:
a. You used Aquamin F Lot
(b)(4)
on 6/28/23 in the manufacture of CalComplex Lot 523008; however, the dietary ingredient was not approved and released from quarantine until 10/10/23.
b. You used Calcium Pyruvate Lot
(b)(4)
on 9/8/22 in the manufacture of Calcium Pyruvate Lot 150822; however, the dietary ingredient was not approved and released from quarantine until 9/26/22.
We have reviewed your response dated December 7 ,2023, in which you state you investigated and concluded that personnel turnover and insufficient training was the most probable cause of the component’s documented release timing delay. Additionally, you state CalComplex Lot 523008 and Calcium Pyruvate Lot 150822 met all strength claims. You provided finished product strength test results for CalComplex Lot 523008 and Calcium Pyruvate Lot 150822, updated procedure 12-D-01 (Raw material Component Identity Testing), and staff training records; however, you did not provide documentation to support that your quality control operations are approving and releasing from quarantine all components before use in the manufacture of a dietary supplement.
5. Your quality control operations failed to approve for release, or reject, any packaged and labeled dietary supplements for distribution, as required by 21 CFR 111.127(h). Specifically, your distribution records show that your quality control signed and released Chromium Picolinate Lot 40223 on 7/18/2023, after the finished dietary supplement was shipped on 6/19/2023. Your distribution records further show that your quality control signed and released CalComplex Lot 523008 on 8/22/2023, after the finished dietary supplement was shipped on 8/9/2023.
We have reviewed your response dated December 7, 2023, in which you state there was confusion and disorganization of the batch records which unintentionally led to unexpected timing gaps between shipping to the client and your formal material release paperwork. You also provided your updated procedure 12-E-01 Testing and Release of Finished Product, training records, and updated disposition records for Chromium Picolinate Lot 40223 and CalComplex Lot 523008. However, you did not provide documentation to support that you are distributing finished dietary supplements only after approval and release by your quality control unit.
6. You failed to prepare and follow master manufacturing records that include written instructions that include 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, and 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 111.205 and 21 CFR 111.210(h)(1) and (h)(3). Specifically, your manufacturing records for CalComplex, Calcium Pyruvate, and Chromium Picolinate do not include written instructions for manufacturing, packaging, and labeling steps, nor do the records identify those points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
We have reviewed your response dated December 7 ,2023, in which you provided revised MMR templates for the CalComplex, Calcium Pyruvate, and Chromium Picolinate. However, we are unable to fully evaluate your proposed corrective actions because you did not provide documentation demonstrating that you have implemented and are following your corrective action in the master manufacturing records for a manufactured batch of CalComplex, Calcium Pyruvate, and Chromium Picolinate.
7. Your batch production record failed to include all information required by 21 CFR 111.260. Specifically:
a. Batch production records for Calcium Pyruvate Lot 150822, Chromium Picolinate Lot 40223, and CalComplex Lot 523008 failed to include a statement of the actual yield at appropriate phases of the processing, as required by 21 CFR 111.260(f);
b. Batch production records for Calcium Pyruvate Lot 150822, Chromium Picolinate Lot 40223, and CalComplex Lot 523008 failed to include the identity of each component used, as required by 21 CFR 111.260(e). For example, the Master Formula page for Calcium Pyruvate Lot 150822 has the weigh out of each component that totals
(b)(4)
; however, there is a
(b)(4)
set of weights
(b)(4)
that does not have the identity of the component documented;
c. Batch production records for Calcium Pyruvate Lot 150822, Chromium Picolinate Lot 40223, and CalComplex Lot 523008 failed to include an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record, as required by 21 CFR 111.260(k)(2);
d. Batch production records did not include documentation at the time of performance that quality control personnel reviewed the batch production records, as required by 21 CFR 111.260(l)(1). Specifically, for Chromium Picolinate Lot 40223, there was no quality review sign off for labeling and packaging materials. For CalComplex Lot 523008 there was no quality review sign off for labeling materials.
We have reviewed your response dated December 7 ,2023. Your response includes updated BPRs. However, we are unable to further evaluate your response since it did not include any evidence that you have implemented the proposed corrective actions in executed batch production records.
Misbranded Dietary Supplements
In addition, we reviewed product labels collected during the inspection and have determined the Calcium Pyruvate, Chromium Picolinate, and Calcium Complex Formula #3 (CalComplex) products you manufacture are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:
1. The Calcium Pyruvate and Chromium Picolinate 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 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement.
2. The CalComplex, Calcium Pyruvate, and Chromium Picolinate 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 presentation of the nutrition information on the labeling of these products does not comply with 21 CFR 101.36 and 101.9. For example:
a. For the CalComplex product:
i. The presentation of the (b)(2)-dietary ingredients is not in the order as set forth in 21 CFR 101.36(b)(2)(i)(B). For example, the declaration of calcium must appear before the declaration of phosphorus.
b. For your Calcium Pyruvate product:
i. The title, “Supplement Facts”, is not set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i).
ii. The label lists calcium pyruvate which is not the nomenclature specified for calcium in 21 CFR 101.9(c)(8) or 21 CFR 101.36(b)(2). The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", e.g., "Calcium (as calcium pyruvate)". When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement [21 CFR 101.36(d)].
iii. The Supplement Facts label must list the % Daily Value for (b)(2)-dietary ingredients by calculating the dietary ingredient’s quantitative amount by weight per serving divided by the established RDI noted in 21 CFR 101.9(c)(8)(iv), and expressed to the nearest whole percent, in accordance with 21 CFR 101.36(b)(2)(iii)(B).
iv. The Supplement Facts label format requirements including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e).
c. For the Chromium Picolinate product:
i. The title, “Supplement Facts”, is not set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i).
ii. The Supplement Facts label must list the % Daily Value for (b)(2)-dietary ingredients by calculating the dietary ingredient’s quantitative amount by weight per serving divided by the established RDI noted in 21 CFR 101.9(c)(8)(iv), and expressed to the nearest whole percent, in accordance with 21 CFR 101.36(b)(2)(iii)(B).
iii. The Supplement Facts label format requirements including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e).
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.
We also have the following comments:
For the CalComplex product, the statement “Allergen Warning” appears before the Contains statement, which is considered intervening material.
We note that the CalComplex product declares “Naticol Marine Collagen.” Naticol’s website at https://www.naticol.com/en/naticol-en/ describes their ingredients as “a range of bioactive and bioavailable marine collagen peptides of natural origin.” If the dietary ingredient used in this product is marine peptides, that ingredient must be declared by its common or usual name.
For the Cal Complex product, “Aquamin™” is not the common or usual name for
Lithothamnion
spp.
For the Calcium Pyruvate product, the statement “**Daily Value not Established” must bewithin the Supplements Facts label.
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 directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
or emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.
Refer to the Unique Identification Number CMS 672954 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations- West Division 5
Content current as of:
07/23/2024
Regulated Product(s)
Dietary Supplements