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WARNING LETTER

Ingenue Care MARCS-CMS 574836 —


Delivery Method:
VIA SIGNATURE CONFIRMED DELIVE
Product:
Drugs

Recipient:
Recipient Name
Mr. William Kim
Recipient Title
President
Ingenue Care

14715 Carmenita Road
Norwalk, CA 90650
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

19701 Fairchild
Irvine, CA 92612-2506
United States


WARNING LETTER

VIA SIGNATURE CONFIRMED DELIVERY

May 31, 2019

Mr. William Kim
President
Ingenue Care
14715 Carmenita Road
Norwalk, CA 90650

Dear Mr. Kim:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Ingenue Care at 14715 Carmenita Road, Norwalk, CA, on November 16, November 26, November 30, and December 6, 2018.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

Your firm manufactures and distributes Lucidaroma Zeroma7, Zen Relief Blended Natural Soothing Roll On, Lucid Aroma Lavender Roll On, Lucid Aroma Lemon Roll On, Lucid Aroma Harmonious Roll On, Lucid Aroma Sweet Orange Roll On, Lucid Aroma Inspiration Blend Roll On, Lucid Aroma Lavender Essential Oil, Lucid Aroma Lemongrass Essential Oil, Lucid Aroma Peppermint Essential Oil, Lucid Aroma Tea Tree Essential Oil, Lucid Aroma Blood Orange Essential Oil, and Lucid Aroma Eucalyptus Essential Oil. These products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Your products Lucidaroma Zeroma7, Lucid Aroma Lavender Roll On, Lucid Aroma Sweet Orange Roll On, Lucid Aroma Lavender Essential Oil, Lucid Aroma Lemongrass Essential Oil, Lucid Aroma Tea Tree Essential Oil, Lucid Aroma Blood Orange Essential Oil, and Lucid Aroma Eucalyptus Essential Oil are also misbranded drugs in violation of section 502 of the FD&C Act, 21 U.S.C. 352. Introduction of such products into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a). These violations are described in more detail below.

We did not receive a response to the Form FDA 483 issued at the close of the inspection.

During our inspection, our investigator observed specific violations including, but not limited to, the following.

CGMP Charges

1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and (b)).

Your firm released over-the-counter (OTC) drug products such as Zeroma7 and ZenRelief to the U. S. market without adequate testing for identity and strength of each active ingredient. In addition, your firm released these finished drug products without adequate testing for total aerobic microbial count and objectionable microorganisms.

Testing is essential to ensure that the drug products you manufacture meet established specifications for the chemical and microbial attributes they purport to possess.

In response to this letter, provide:

• Your established procedures for testing all your finished drug dosage products according to your firm’s specifications
• Your completed chemical and microbial analytical method validation, equipment validation, and updated test methods and specifications for your drug products before a batch disposition decision
• A summary of test results obtained from testing retain samples of all drug products within expiry that have been distributed in the United States. These test results should include identity and strength of active ingredients, and all other appropriate quality attributes

2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).

Your firm failed to adequately test incoming raw materials used in the manufacture of your drug products, including active pharmaceutical ingredients (API) and other components, for their identity, strength, and other quality attributes. Instead, your firm used API and other materials in manufacturing based on the certificate of analysis (COA) from your supplier without establishing the reliability of the supplier’s analysis through appropriate validation and ensuring at least one specific identity test is conducted for each lot.

In response to this letter, provide:

• Your procedure for incoming component testing. Include your corrective action and preventive action (CAPA) plan to ensure that you conduct at least one specific identity test for each incoming lot (both active and inactive ingredients). Describe in detail how you plan to test each incoming component lot for conformity with all appropriate written specifications for purity, strength, and quality. If you accept your supplier’s COA in lieu of testing each component lot for purity, strength, and quality, specify how you plan to establish the reliability of your suppliers’ test results for these attributes through periodic validation.
• A comprehensive, independent review of your materials system to determine whether all containers, closures, and ingredients from each supplier are adequately qualified; drugs are assigned appropriate expiration or retest dates; and incoming material lot controls are adequate to prevent use of unsuitable containers, closures, and components.

3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

You did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products remain acceptable throughout their labeled expiry period. During the inspection, management indicated that a two-year expiration date is assigned to Zeroma7 3 oz. and ZenRelief 3 oz. based on expiration dates observed on similar marketed products without performing accelerated or long-term stability testing.

In response to this letter, provide:

• Your standard operating procedure describing your firm’s ongoing stability program
• Your stability data demonstrating that each OTC drug product distributed to the United States meet all specifications throughout its expiry

4. Your firm failed to establish a quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a) and (d)).

Your firm lacked an adequate quality control unit. Your firm also failed to establish written procedures for different quality control unit operations. For example, there were no procedures addressing the quality control unit, review of complaints, CGMP training, process deviations, investigations, or basic drug manufacturing operations.

Furthermore, your firm lacks documentation to demonstrate acceptability of batch manufacturing and quality. For instance, you lacked records relating to:

• Change control
• Annual product quality reviews
• Approval or rejection of your drug products

In addition, your firm failed to provide batch production and control records.

In response to this letter, provide your corrective actions to ensure that you:

• Establish an adequate quality control unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality
• Establish adequate procedures in accordance with CGMP covering all aspects of your facility and operations that may compromise the identity, strength, quality, and purity of your drug products
• Provide your timeline to perform annual product reviews for drug products within expiry
• Provide adequate batch production and control records

See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at:
https://www.fda.gov/media/71023/download.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Unapproved New Drug Charges

Lucidaroma Zeroma7, Zen Relief Blended Natural Soothing Roll On, Lucid Aroma Lavender Roll On, Lucid Aroma Lemon Roll On, Lucid Aroma Harmonious Roll On, Lucid Aroma Sweet Orange Roll On, Lucid Aroma Inspiration Blend Roll On, Lucid Aroma Lavender Essential Oil, Lucid Aroma Lemongrass Essential Oil, Lucid Aroma Peppermint Essential Oil, Lucid Aroma Tea Tree Essential Oil, Lucid Aroma Blood Orange Essential Oil, and Lucid Aroma Eucalyptus Essential Oil are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.

Examples of claims observed on the product label and/or website labeling for your before-named products that establish the intended uses as defined by 21 CFR 201.128 include, but may not be limited to, the following:

Lucidaroma Zeroma7

Statements that appear on the product label:

“Muscle & Joint Pain Relief . . . Aroma therapy blend essential oil for temporarily relieves (sic) minor aches, pains of muscles and joints associated with: ■ Arthritis pains ■ Simple backache ■ Strains ■ Bruises ■”

Statements that appear on the website, www.ingenuecare.com:

“Great for basic aches and pains. Zeroma7 is composed of a truly natural plant extracts (sic) in combination with Aloe Vera and witch hazel that get rid of pain the natural way. The combination of these extracts penetrates immediately and purifies tight, sore joints and relieves arthritic pain, muscle soreness and inflammation.”

Zen Relief Blended Natural Soothing Roll On

Statements that appear on the product label:

“Pain Relief & Post Meditation . . . Aroma therapy blend essential oils helps calm feelings for temporary relief of minor aches, pains of muscles & joints associated with: ■ Arthritis pains ■ Simple backache ■ Muscle pains”

Statements that appear on the website, www.ingenuecare.com:

“Great for basic aches and pains . . . Zen Relief is composed of a truly natural plant extracts (sic) in combination with Aloe Vera and Lavender that get rid of pain the natural way. The combination of these extracts penetrates immediately and purifies tight, sore joints and relieves arthritic pain, muscle soreness and inflammation.”

Lucid Aroma Lavender Roll On

Statements that appear on the website, www.ingenuecare.com:

“Reduce anxiety . . . Help burns and cuts”

“[L]avender oil may be useful for treating anxiety, insomnia[,] depression . . ..”

Lucid Aroma Lemon Roll On

Statement that appears on the website, www.ingenuecare.com:

“Improve blood circulation”

Lucid Aroma Harmonious Roll On

Statement that appears on the website, www.ingenuecare.com:

“Help improve memory . . . Kill germs . . . Help reduce minor headache”

Lucid Aroma Sweet Orange Roll On

Statement that appears on the website, www.ingenuecare.com:

“Increasing circulation . . . Easing anxiety . . . Natural Antibacterial”

Lucid Aroma Inspiration Blend Roll On

Statement that appears on the website, www.ingenuecare.com:

“Reduce headache . . . Help sinus problem . . . Help fight common cold”

Lucid Aroma Lavender Essential Oil

Statements that appear on the website, www.ingenuecare.com:

“Reduce anxiety . . . Help burns and cuts . . . Antidepressant effect”

“[L]avender oil may be useful for treating anxiety, insomnia[,] depression . . ..”

Lucid Aroma Lemongrass Essential Oil

Statement that appears on the website, www.ingenuecare.com:

“Effect on relieving anxiety and tension . . . Disinfection . . . Muscle pain relief”

Lucid Aroma Peppermint Essential Oil

Statement that appears on the website, www.ingenuecare.com:

“Decongestant . . . Muscle pain relief . . . Cramps . . . Digestion issues . . . Nausea”

Lucid Aroma Tea Tree Essential Oil

Statements that appear on the website, www.ingenuecare.com:

“Acne . . . Bacterial & [f]ungal infections . . . Congestion and respiratory tract infections . . . Psoriasis . . . Itchy insect bites, sores and sunburns”

“It can help fight all three categories of infectious organisms (bacterial, fungi, and viruses) . . ..”

“Acne . . . Bacterial infections . . . Cold sores . . . Congestion and respiratory tract infections . . . Earaches . . . Fungal infections (especially Candida, jock itch, athlete’s foot and toenail fungus) . . . Head lice . . . MRSA . . . Psoriasis . . . Itchy insect bites, sores and sunburns”

Lucid Aroma Blood Orange Essential Oil

Statement that appears on the website, www.ingenuecare.com:

“[S]edative and antidepressant effects . . . Stabilize your digestive system and help with cramps . . . Relieve constipation and diarrhea symptoms”

Lucid Aroma Eucalyptus Essential Oil

Statement that appears on the website, www.ingenuecare.com:

“Eucalyptus essential oil is highly effective for treating respiratory problems, such as asthma, bronchitis, COPD, pneumonia and even tuberculosis. Using eucalyptus for asthma is a proven treatment that dilates the blood vessels and allows more oxygen into the lungs.”

Drug products intended for external analgesic indications such as the temporary relief of minor aches and pains of muscles and joints are being evaluated as part of the OTC Drug Review. They have been proposed to be classified as generally recognized as safe and effective and not misbranded under the Tentative Final Monograph (TFM) for External Analgesic Drug Products for Over-the-Counter Human Use (48 Federal Register (FR) 5852, February 8, 1983) if they meet each condition in the TFM and each general condition in 21 CFR 330.1. Pending the promulgation of a final rule, the agency generally does not intend to pursue regulatory action against products marketed in accordance with the conditions proposed in the TFM and each general condition in 21 CFR 330.1. Such marketing, however, is subject to the risk that a final rule may require reformulation and/or relabeling or FDA approval through the “new drug” procedures of the FD&C Act (section 505). The labeling for such drugs, like all OTC drugs, must comply with all of the requirements of section 502 of the FD&C Act and all pertinent regulations found in 21 CFR. However, Lucidaroma Zeroma7 and Zen Relief Blended Natural Soothing Roll On do not meet these conditions for the reasons explained below.

The labeling and formulations for Lucidaroma Zeroma7 and Zen Relief Blended Natural Soothing Roll On are not consistent with the TFM for External Analgesic Drug Products that describes acceptable active ingredients for external analgesic drug products, see 48 FR 5852 at 5868. According to their labels, both Lucidaroma Zeroma7 and Zen Relief Blended Natural Soothing Roll On contain peppermint oil 8% and camphor oil 8% as the active ingredients. Peppermint oil is not an ingredient included in the External Analgesics TFM. Further, the external analgesics TFM limits general anti-inflammatory claims and anti-inflammatory claims related to (non-serious conditions of) minor skin irritations and rashes for external analgesic products containing hydrocortisone or hydrocortisone acetate as the active ingredient.

Thus, as formulated and labeled, Lucidaroma Zeroma7 and Zen Relief Blended Natural Soothing Roll On do not comply with the TFM described above. Additionally, we are not aware of a similar OTC product as formulated and labeled that was available in the U.S. market on or before the inception of the OTC Drug Review. Furthermore, we are not aware of sufficient evidence to show Lucidaroma Zeroma7 and Zen Relief Blended Natural Soothing Roll On, as formulated and labeled, are generally recognized as safe and effective. Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Your firm’s products Lucid Aroma Lavender Roll On, Lucid Aroma Lemon Roll On, Lucid Aroma Harmonious Roll On, Lucid Aroma Sweet Orange Roll On, Lucid Aroma Inspiration Blend Roll On, Lucid Aroma Lavender Essential Oil, Lucid Aroma Lemongrass Essential Oil, Lucid Aroma Peppermint Essential Oil, Lucid Aroma Tea Tree Essential Oil, Lucid Aroma Blood Orange Essential Oil, and Lucid Aroma Eucalyptus Essential Oil, are also “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.

Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA. No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Misbranding Violations

Your firm’s products, Lucid Aroma Lavender Roll On, Lucid Aroma Sweet Orange Roll On, Lucid Aroma Lavender Essential Oil, Lucid Aroma Lemongrass Essential Oil, Lucid Aroma Tea Tree Essential Oil, Lucid Aroma Blood Orange Essential Oil, and Lucid Aroma Eucalyptus Essential Oil, are misbranded under 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). According to section 502(f)(1) of the FD&C Act, a drug is misbranded if, among other things, it fails to bear adequate directions for use. “Adequate directions for use” is defined in 21 CFR 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended.” Your products are intended for use in the treatment of anxiety, depression, infectious diseases, and respiratory tract diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Because the conditions for which your products are intended require the supervision of a practitioner licensed by law to administer drugs for such conditions, adequate directions cannot be written so that a layperson can use your products safely. Moreover, your products are not exempt, under 21 CFR 201.100(c)(2) or 201.115, from the requirements that their labeling bear adequate directions for use because no FDA-approved applications are in effect for your products. Thus, your products’ labeling fail to bear adequate directions for their intended uses, which causes the products to be misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).

Additionally, Lucidaroma Zeroma7 is misbranded within the meaning of section 502(a) of the FD&C Act, 21 U.S.C. 352(a) because the label identifies the product as a “Roll-on” while the directions for use instruct the user to “Remove patch from film.” Such a discrepancy between dosage form and application of product is false and misleading in that it causes a likelihood of confusion or misunderstanding on the part of a reasonable consumer regarding the type of product available for purchase and use.

The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.

Until these violations are corrected, we may withhold approval of pending drug applications listing your facility. We may re-inspect to verify that you have completed your corrective actions. We may also refuse your requests for export certificates.

Within fifteen (15) working days of receipt of this letter, please provide a written response to this office. Your response should specify all the steps your firm has taken to correct and prevent the recurrence of the violations cited in this letter. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Your written response should refer to unique identifier CMS 574836 and be sent to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road
Irvine, CA 92612

If you have questions regarding the contents of this letter, please contact William V. Millar, Compliance Officer at (510) 337-6896, or by email at william.millar@fda.hhs.gov.

Sincerely,
/S/

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV