Virgin Scent Inc. dba Artnaturals

The U.S. Food and Drug Administration inspected your drug manufacturing facility, Virgin Scent Inc. dba Artnaturals, FEI 3012303419, at 16325 S. Avalon Blvd, Gardena, CA 90248 from February 14 to March 11, 2022.

This inspection followed FDA laboratory testing of a batch of artnaturals SCENT FREE HAND SANITIZER manufactured at your facility and obtained in U.S. distribution, which was found to contain unacceptable levels of impurities. The FDA determined that hand sanitizer drug products produced by your contract manufacturer, Gordon Laboratories Inc., and distributed on your behalf, including artnaturals SCENT FREE HAND SANITIZER are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B).1

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 FD&C Act), 21 U.S.C. 351(a)(2)(B). Virgin Scent’s Artnaturals Hand Sanitizer (NDC 78706-018-00), Artnaturals Hand Sanitizer Gel (NDC 78706-000-00), Artnaturals Hand Sanitizer Moisturizing Formula (NDC 78706-004-02), Sanitizing Wipes (NDC 74642-005-00), Hand Sanitizer Gel (NDC 74642-002-16), Hand Sanitizer (NDC 74642-007-01), 65% alcohol hand sanitizer (no water) (NDC 74642-001-01), Artnaturals Hand Sanitizer Natural Elements Cleansing Formula (NDC 78706-003-01), Artnaturals Isopropyl Alcohol 70% (NDC 78706-001-16), Artnaturals Isopropyl Alcohol 91% (78706-002-01), and Artnaturals Spray Sanitizer Refill are not duly listed with the FDA as required by section 510(j) of the FD&C Act, 21 U.S.C 360(j). Failure to properly list a drug product is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p) and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

Your firm distributed artnaturals SCENT FREE HAND SANITIZER. FDA laboratory testing of a batch of artnaturals SCENT FREE HAND SANITIZER that was distributed by your facility and obtained from U.S. distribution was found to contain impurities at unacceptable levels.1 Benzene impurity levels were found to be approximately (b)(4) parts per million (ppm) while acetaldehyde and acetal impurities were found to be approximately (b)(4) ppm and (b)(4) ppm, respectively.

Acetaldehyde appears to be genotoxic, and potentially carcinogenic, when in direct contact with tissues. The FDA has alerted all drug manufacturers to the known risk factors for contamination with benzene. For more information see https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs.

The FDA repeatedly tried to contact you regarding the violative sample results and potential market action; however, you failed to respond. On October 4, 2021, the FDA notified the public of the unacceptable impurity results for artnaturals SCENT FREE HAND SANITIZER at the following website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use.

On October 8, 2021, the FDA held a teleconference with you, and your contract manufacturer, Gordon Laboratories Inc., who is a contract manufacturer of artnaturals SCENT FREE HAND SANITIZER, and we recommended you consider removing the adulterated batch of artnaturals SCENT FREE HAND SANITIZER drug product currently in distribution from the U.S. market. On October 26, 2021, you and Gordon Laboratories Inc. issued a voluntary nationwide recall of two batches of artnaturals SCENT FREE HAND SANITIZER due to the presence of benzene, acetaldehyde, and acetal impurities. On April 22, 2022, the scope of the recall of artnaturals SCENT FREE HAND SANITIZER was expanded to include at least 38 additional batches because they were manufactured using some of the same ingredients as the two batches initially recalled. Refer to the following FDA website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/artnaturalsr-issues-voluntary-recall-limited-batches-8oz-bottles-scent-free-hand-sanitizer-due.

The contamination with benzene, acetaldehyde, and acetal impurities in a drug product purported to be manufactured in your facility in addition to the significant violations documented in the inspection, demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.1

Following the February 14 to March 11, 2022, inspection of your facility, we have not received a response from your firm regarding corrective actions to the observations identified during the inspection in our Form FDA 483.

During our inspection, our investigators observed specific violations including, but not limited to, the following:

1. 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).

Quality Unit (QU) Personnel and Procedures

Your firm failed to implement written procedures to establish a QU with the CGMP responsibilities and authority to oversee the manufacture of your over-the-counter (OTC) drug products. In an affidavit signed by your co-owner, you stated that there are no written procedures that establish and describe the responsibilities of a QU. You stated that an employee previously reviewed certificates of analysis but was no longer with your company and could not identify a current employee with quality responsibilities. You failed to provide written procedures for investigations, recalls, complaint handling, the approval of manufacturing instructions, and the evaluation and approval or rejection of finished drug product batches before release to the market. Additionally, your firm could not provide distribution records for your artnaturals hand sanitizer drug products.

The CGMP requirements assign responsibilities to the QU which include approving or rejecting incoming materials, in-process materials, and drug products; ensuring that controls are implemented and completed satisfactorily during manufacturing operations; and reviewing production records and investigating any unexplained discrepancies. You have not demonstrated that you have a QU capable of these responsibilities.

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.

Inadequate QU Oversight of your Contract Manufacturers

Your QU failed to implement adequate oversight and controls for your contract manufacturers of your OTC drug products, which led to your use of substandard contract manufacturers. Since 2022, the FDA has taken the following actions in response to FD&C Act violations or deficiencies found at your contract manufacturers.

(b)(4) was issued a Warning Letter dated (b)(4), for having an inadequate quality control unit (21 CFR 211.22(a) and 211.22(d)), failing to examine incoming components (21 CFR 211.84(a)), failing to perform release testing prior to product release (21 CFR 211.165(a)), and failing to record manufacturing information in a batch record (21 CFR 211.188).

Gordon Laboratories Inc., Carson, California (FEI 2012546) was issued a Warning Letter on August 17, 2022, for inadequate investigations (21 CFR 211.192), failing to examine incoming components (21 CFR 211.84(d)(1) and 211.84(d)(2)), and the lack of procedures to control the water system (21 CFR 211.100(a)).

Guangzhou Orchard Aromatherapy & Skin Care Co. Ltd., Guangzhou, Guangdong, China (FEI 3012368173) was added to Import Alert 66-79 on May 16, 2022, and issued a Warning Letter on July 20, 2022, for failing to respond to a request for records and other information pursuant to section 704(a)(4) of the FD&C Act regarding their hand sanitizer manufacturing operations.

Drugs must be manufactured in conformance with CGMP. The FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. The FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

In response to this letter, provide:

A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:

o A determination of whether procedures used by your firm are robust and appropriate. o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices. o A complete and final review of each batch and its related information before the QU disposition decision. o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. o Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.

Your firm lacked adequate batch and control records that document your manufacturing operations. Your firm filled consumer hand sanitizer drug product containers from a container of bulk hand sanitizer. Although you provided a document that recorded the number of bottles filled, you failed to provide and maintain manufacturing batch records for your filling operations, including equipment used, identification of persons performing each step, description of containers and closures used, complete labeling controls including specimens, and actual yield.

In response to this letter, provide:

A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.

A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability, and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.

Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.

Based upon the information obtained from the inspection performed between February 14 and March 11, 2022, Virgin Scent Inc dba Artnaturals (FEI: 3012303419) has been identified as a drug repackager of Artnaturals Hand Sanitizer (NDC 78706-018-00), Artnaturals Hand Sanitizer Gel (NDC 78706-000-00), Artnaturals Hand Sanitizer Moisturizing Formula (NDC 78706-004-02), Sanitizing Wipes (NDC 74642-005-00), Hand Sanitizer Gel (NDC 74642-002-16), Hand Sanitizer (NDC 74642-007-01), 65% alcohol hand sanitizer (no water) (NDC 74642-001-01), Artnaturals Hand Sanitizer Natural Elements Cleansing Formula (NDC 78706-003-01), Artnaturals Isopropyl Alcohol 91% (NDC 78706-002-01), Artnaturals Isopropyl Alcohol 70% (NDC 78706-001-16), and Artnaturals Spray Sanitizer Refill. Under section 510(i)(1) of the Act 21 U.S.C. 360(i)(1), Virgin Scent Inc dba Artnaturals is required to submit registration information annually by electronic means for each establishment it owns or operates that is engaged in the manufacture (including repackaging), preparation, propagation, compounding, or processing of a drug that is in commercial distribution in the United States. Virgin Scent Inc dba Artnaturals has not fulfilled its registration requirements. As a drug manufacturer, it is your responsibility to ensure complete and accurate registration information. You have failed to fulfill your establishment registration obligations under section 510 of the FD&C Act, which is prohibited under section 301(p), 21 U.S.C 360 and 331(p). As a result, all drugs you manufacture in this establishment are misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

In addition, the drug listing submissions for Artnaturals Hand Sanitizer (NDC 78706-018-00), Artnaturals Hand Sanitizer Gel (NDC 78706-000-00), Artnaturals Hand Sanitizer Moisturizing Formula (NDC 78706-004-02), Sanitizing Wipes (NDC 74642-005-00), Hand Sanitizer Gel (NDC 74642-002-16), Hand Sanitizer (NDC 74642-007-01), 65% alcohol hand sanitizer (no water) (NDC 74642-001-01), Artnaturals Hand Sanitizer Natural Elements Cleansing Formula (NDC 78706-003-01), Artnaturals Isopropyl Alcohol 91% (NDC 78706-002-01), Artnaturals Isopropyl Alcohol 70% (NDC 78706-001-16), and Artnaturals Spray Sanitizer Refill do not reference Virgin Scent Inc dba Artnaturals (FEI 3012303419) as the repackager. Under section 510 of the FD&C Act as amended and 21 CFR (21 U.S.C. 360(j)(1), 21 CFR 207.17 and 207.41), all drugs manufactured, prepared, propagated, compounded, or processed for U.S. commercial distribution must be listed with the FDA. Failure to list these drugs with the FDA with the correct manufacturing establishment as required by section 510 of the FD&C Act, 21 U.S.C. 360(j), is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Failure to properly list a drug with the FDA will also render it misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

Based upon the nature of the violations we identified at your firm and if your firm intends to resume manufacturing drugs for the U.S. market, you should engage 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.

On September 30, 2021, a significant amount of your hand sanitizer inventory was destroyed in a fire at your facility. You stated that any unused totes of bulk hand sanitizer were likely destroyed in the fire. You provided an inventory of remaining OTC products which included over (b)(4) bottles of artnaturals SCENT FREE HAND SANITIZER that may have been exposed to improper conditions. While you stated your intent to cease OTC drug distribution, you informed our investigators that you may continue distributing your remaining inventory.

Per 21 CFR 211.208, any drug products that have been subject to improper storage conditions including temperature extremes and smoke shall not be salvaged and returned to the marketplace. If you are unsure of the conditions the products were held and intend to introduce any recovered hand sanitizer drug products into interstate commerce, provide your rationale and evidence such as the testing of this material which demonstrates that the products were not exposed to improper conditions, and that the products remain safe and meet all applicable standards of identity, strength, quality, and purity.

The distributing of product that has been exposed to improper conditions is prohibited. Provide a final reconciliation of your OTC drug product inventory following completion of your fire clean-up operations.

We also note that the documents that you were not able to provide in the charges above describing the responsibility of the QU and documenting your manufacturing operations were not lost in the warehouse fire.

We acknowledge your commitment to cease production of drugs for the U.S. market by Virgin Scent. In response to this letter, clarify whether you intend to resume manufacturing any drugs for the U.S. market in the future. If you plan to resume manufacturing drugs for the U.S. market from your current facility or a new location, or continue to use contract manufacturers, notify this office in writing.

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 the FDA to withhold issuance of Export Certificates. The 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.

Please send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:

CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV U.S. Food & Drug Administration 19701 Fairchild Road Irvine, California 92612-2506

Please identify your responses with the unique identifier: CMS 631780

If you have questions regarding the contents of this letter, please contact Andrew Haack, Compliance Officer by telephone at 206-340-8212 or email at Andrew.Haack@fda.hhs.gov.