Kabana Skin Care LLC

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kabana Skin Care LLC, FEI 3015118914, at 685 S Arthur Ave Unit 9b, Louisville, CO 80027-3141, from February 19 to 20, 2025.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (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).

We reviewed your March 3, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.

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

1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 211.84(d)(2)).

Your firm manufactures over the counter (OTC) drug products, including sunscreens and antibacterial hand sanitizers. You failed to adequately test incoming components, such as ethanol and glycerin, for identity before using them in the manufacture of your drug products.

Identity testing for high-risk drug components ethanol and glycerin include a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for methanol or DEG or EG levels, respectively. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.

In addition, you did not adequately establish the reliability of each of your suppliers’ analyses at appropriate intervals.

Ethanol

You failed to adequately test each shipment of each lot of ethanol, used as an active pharmaceutical ingredient, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, at https://www.fda.gov/media/173005/download.

Glycerin

You failed to adequately test each shipment of each lot of glycerin, used as an inactive ingredient, for diethylene glycol (DEG) or ethylene glycol (EG) contamination.

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

Without adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have the responsibility to sample, test, and examine drug components before use in production to assure adequate quality.

In response to this letter, provide:

A commitment to provide methanol or DEG and EG test results, as applicable, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated, marketed finished drug product batches for the presence of methanol or DEG and EG, as applicable.

A full risk assessment for drug products that are within expiry which contain any ingredient at risk for methanol or DEG and EG contamination (including, but not limited to, ethanol and glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related marketed drug product that could contain methanol or DEG and EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.

2. 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 (21 CFR 211.165(a)).

You failed to adequately test batches of your drug products before release and distribution. For example, you stated during the inspection that you did not perform chemical or microbiological tests on your finished drug products prior to release and distribution into the U.S. market.

Appropriate release testing, including identity and strength testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have scientific evidence to support whether your drug products conform to appropriate specifications before release.

3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

You lacked adequate quality oversight for the manufacture of your drug products. For example, you failed to ensure:

Establishment of suitable quality oversight procedures (e.g., raw material handling, review of production records, investigations, complaints, recalls) (21 CFR 211.22(a) and 211.22(d)).

Establishment of an adequate stability program to support the labeled expiration dates (21 CFR 211.137 and 211.166).

Establishment of appropriate written procedures for production and process controls (21 CFR 211.100(a)).

Establishment of adequate equipment cleaning and maintenance procedures (21 CFR 211.67(a) and 211.67(b)).

Your firm’s quality systems are inadequate. 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.

On March 12, 2025, you communicated your commitment to permanently cease manufacturing and distribution of all drugs for the U.S. market and agreed to a voluntary recall of all drugs in current distribution in the United States.

We acknowledge your commitment to cease production of all OTC drugs and that you deregistered your facility as a drug manufacturer.

If you plan to resume any drug manufacturing operations regulated under the FD&C Act, notify this office before resuming your operations. If your firm intends to resume manufacturing drugs, you should engage a consultant qualified to evaluate your operations 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.

In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3015118914 and ATTN: Carlos Gonzalez.