The United States Food and Drug Administration (FDA) conducted an inspection of your distribution facility located at 200 Peddycord Park Court, Kernersville, NC from February 10-12, 2020. Your firm distributes food, dietary supplement, and cosmetic products that are contract manufactured for you under your firm’s name. During the inspection, our investigator collected product labels for your products. Based on our inspection and subsequent review of your product labels and labeling, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s homepage at www.fda.gov.
At the close of the inspection, a FDA Form 483, Inspectional Observations was issued. We acknowledge receipt of your written response submitted on March 2, 2020. We have reviewed your response and discuss your significant violations and your corrective actions below.
Adulterated Dietary Supplements
Your dietary supplement products are 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 FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements found in Title 21 of the Code of Federal Regulation (CFR) Part 111 (21 CFR Part 111). During the inspection of your facility, our investigator observed the following significant violations of CGMP requirements:
1. You failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.140(b)(2) [see also 21 CFR 111.127(h)]. Specifically, your firm distributes the dietary supplements Multivitamin Multimineral 100 and gorgeous roses that are contract manufactured for you, but you had no records of a quality control review, approval, or rejection for your Multivitamin Multimineral 100 or gorgeous roses products. During the inspection, your logistics manager informed our investigator that he reviews the Certificate of Analysis (COA) received for each dietary supplement from the contract manufacturer and your Standard Operating Procedure (SOP) states “Check/Compare the Certificate of Analysis.” However, you had no records showing the date that the review, approval, or rejection was performed or the signature of the person performing the review, approval, or rejection, as required by 21 CFR 111.140(b)(2). This lack of review is further evidenced by the investigator’s observation that the COA for your Multivitamin Multimineral 100 lists “silica” as one of the “other ingredients,” but silica is not present on the product label.
In your response received on March 2, 2020, you state that you had an SOP in place but found it to be insufficient. You state that “upon completion of the inspection of all components and labels, all processes are now signed and dated by Quality Control to verify in writing that this process is being followed.” You also state that “any deficiencies found at the time of this last inspection have been rectified and filed.” We cannot evaluate the adequacy of your response because you did not provide supporting documentation, such as a copy of the Quality Control personnel process, updated labels, or examples of documents signed and dated by your Quality Control personnel.
2. You failed to make and keep records sufficient to meet the requirements of 21 CFR 111.570(b) in that your complaint procedure does not ensure that the requirements of 21 CFR 111.570(b)(2) are met. Specifically, your complaint procedure requires that information required in the customer complaint template be obtained. However, the template does not require that the following information be documented:
a. Documentation by the person who reviews the product complaint at the time of performance;
b. The batch, lot, or control number of the dietary supplement, if available;
c. The date the complaint was received;
d. How the product was used, if known;
e. The reply to the complainant, if any; and
f. Findings of the investigation and follow-up action taken when an investigation is performed.
Your March 2, 2020 written response states, “An expanded SOP to include much more detail has been established and instituted for all Product Complaints emphasizing the role of Quality Control.” You further identified the associated actions that will be performed by quality control. We are unable to evaluate the adequacy of your corrective action because you did not provide supporting documentation, such as the referenced SOP.
Once the complaint information has been received, a qualified person must review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR Part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury, as required by 21 CFR 111.560(a) and investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR Part 111. Further, quality control personnel must 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, as required by 21 CFR 111.560(b). The 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 111.560(c).
3. Your written returned dietary supplement procedure fails to meet the requirements of 21 CFR 111.535(b) in that your procedure does not require you to make a material review and disposition decision, as required by 21 CFR 111.510 or to conduct an investigation of the manufacturing processes if the reason for the return of the supplement implicates other batches, as required by 21 CFR 111.530. Specifically, your written returned dietary supplement procedure does not include a material review and disposition decision.
Examples of your “RETURNS – Check In and Inspection Report” were also provided with your procedure. However, the procedure does not require, and the report does not include, documentation of the information required by 21 CFR 111.535(b)(2) and (b)(3):
a. Any material review and disposition decision on a returned dietary supplement;
b. The results of any testing or examination conducted to determine compliance with product specifications established under 111.70(e)
In your March 2, 2020 response, you state that your current SOP “has been refined to further clarify in detail your continued practice of destroying all returned dietary supplements. Our policy has always been and will remain to destroy all returned dietary supplements because of fear of contamination. Quality Control will record, document, sign and date all dietary supplement returns and their disposal.” We are unable to evaluate the adequacy of your corrective action because you did not provide supporting documentation, such as the referenced SOP. Additionally, a material review and disposition decision is necessary regardless of whether the returned product will be destroyed; if the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and other batches to determine compliance with specifications, as required by 21 CFR 111.530.
4. You failed to make and keep documentation of training, including the date of training, type of training and persons trained, as required by 21 CFR 111.14(b)(2). Specifically, our investigator determined that your firm has a written training program for new hires and (b)(4) refresher training; however, you do not have any records that document the date of training, type of training, and persons trained.
Your March 2, 2020 written response states, “Training will take place (b)(4). All SOP’s will be reviewed in detail and any (b)(4) training needed will be documented, signed and filed by Quality Control and a Supervisor/CEO or other third party as appropriate.” We are unable to evaluate the adequacy of your corrective action because you did not provide supporting documentation, such as training records.
Misbranded Dietary Supplements
Your Multivitamin Multimineral 100 and gorgeous roses dietary supplement products 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 defined in 21 CFR 101 as follows:
1. Your Multivitamin Multimineral 100 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 all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, Silica is identified in the certificate of analysis under “Other Ingredients”; however, it is not listed on the product label under other ingredients. Additionally, the certificate of analysis shows that the capsule ingredient is “microcrystalline cellulose.” Your label lists “Vegetable cellulose” as an ingredient, but “Vegetable cellulose” is not the common or usual name for microcrystalline cellulose.
2. Your gorgeous roses dietary supplement 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 does not comply with 21 CFR 101.36. Specifically, the % Daily Value for biotin should be 11,110% instead of 1,111%.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws and regulations. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in legal action by the FDA without further notice, including, without limitation, seizure and/or injunction.
We also offer the following comment:
- We note that your gorgeous roses dietary supplement product statement of identity fails to be in a size reasonably related to the most prominent printed matter on the front of the label, as required by 21 CFR 101.3(d).
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and actions taken to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, and other useful information that would assist us in evaluating your corrections. If the corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
