- Delivery Method:
- Via Email
Food & Beverages
Recipient NameMr. Derek W. Reineman
- Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation
6444 E. 26th St
Commerce, CA 90040
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
September 24, 2021
Dear Mr. Reineman:
The U.S. Food and Drug Administration inspected your drug manufacturing facility, Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation, FEI: 3004378632, at 6444 E. 26th St, Commerce, California, from March 29 to April 2, 2021.
FDA determined that hand sanitizer drug products1 manufactured at your facility were adulterated within the meaning of section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 351(a)(2)(A), in that a substance was prepared, packed, or held under insanitary conditions.
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).
In addition, ALKEMI HAND SANITIZER GEL packaged in 33.8oz containers is misbranded under section 502(i) of the FD&C Act, 21 U.S.C. 352(i). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a). This violation is described in more detail below.
Your hand sanitizer drug products were adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, or held under insanitary conditions. You manufactured batches of hand sanitizer in an unlit (b)(4). The (b)(4) was not (b)(4) and was therefore exposed to the outside environment. Filling was performed by inserting a manual pump into a tote of bulk drug product which was left open to the environment during set-up. You did not have any controls in place to prevent contamination of the production environment and the drug products.
We reviewed your April 23, 2021, response to our Form FDA 483 in detail.
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).
Our investigators observed that your quality unit (QU) did not provide adequate oversight for the manufacture of your over-the-counter (OTC) drug products. Your firm manufactured hand sanitizer drug products without performing identification testing of the incoming component and without verification of your supplier’s certificates of analysis (COA). Further, you did not establish specifications for the drug product and distributed finished hand sanitizer drug products without performing release testing.
In your response, you stated that, your agreement with your customer provides that responsibility for hand sanitizer compliance and efficacy rests with your customer. Specifically, both ensuring the quality of incoming components and establishing finished product specifications are the responsibility of your customer. Likewise, you stated that because your customer did not finalize its hand sanitizer formulation and provide finished product specifications, your final product specifications had not been established. As a contract manufacturer, under CGMP, you should not have commenced manufacturing until key quality requirements such as operations and specifications were in place.
Your QU has the responsibility to ensure the quality of components used by your facility and evaluate the quality of finished products to make approval or rejection decisions about each batch. You have quality agreements with several customers regarding the manufacture of hand sanitizer drug products. As a contract manufacturer, quality agreements cannot be used to delegate statutory or regulatory responsibilities to comply with CGMP. You are responsible for the quality of drugs you produce as a contract facility, regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for 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 the following:
• 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
• A list of chemical and microbial test methods and specifications used to analyze each lot of your drug product before making a lot disposition decision, and the associated written procedures.
• The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
• A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
• A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.
• A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
2. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
Your firm manufactured batches of hand sanitizer by attaching a manual pump to a tote of bulk hand sanitizer for bottle filling. During the inspection, you could not provide cleaning records for the manual pump. Additionally, you could not provide procedures for cleaning and cleaning validation studies for this equipment. The manual pump was observed to be wrapped in plastic tape and rubber gloves and was located in an unlit (b)(4). Bulk hand sanitizer received from several suppliers were filled using this equipment.
Further, your firm manufactured hand sanitizer drug products on filling line (b)(4) which is also used to manufacture non-pharmaceutical products (i.e., bottled drinking water). During the inspection, you provided an interim cleaning procedure which lacked sufficient detail to ensure adequate cleaning. You also failed to provide validation studies for this cleaning procedure to ensure that cross-contamination does not occur between hand sanitizer drug products and bottled drinking water.
In your response, you provided a manual pump cleaning procedure that described rinsing the pump with (b)(4) water until the rinse water meets (b)(4) and passes microbial testing. You did not provide validation studies for this method and did not address the adequacy of this method for preventing chemical carry over. Your response did not include a retrospective analysis of the cross-contamination risk between your various drug products and non-drug products.
In response to this letter, provide the following:
• A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one product, including both non-drug products and finished drug products.
• A corrective action preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.
ALKEMI HAND SANITIZER GEL is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in 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 it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a consumer topical antiseptic.
Examples of claims observed on the ALKEMI HAND SANITIZER GEL product label that provides evidence of the intended uses (as defined in 21 CFR 201.128) of the product includes, but may not be limited to, the following:
“Drug Facts . . . Uses: • hand sanitizer to reduce bacteria on the skin . . . Directions: • wet hands thoroughly with product and allow to dry without wiping….”
ALKEMI HAND SANITIZER GEL packaged in 33.8oz containers resemble drinking water bottles customarily purchased by U.S. consumers2. Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading . . .” As such, your clear, colorless hand sanitizer that fills 33.88oz bottle containers that resemble plastic bottles ordinarily used to package drinking water is misbranded under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
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.
During the inspection, (b)(4).
Based upon the nature of the violations we identified at your firm, (b)(4), 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.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in 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 since our inspection to correct your 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.
Your response should be sent electronically to ORAPHARM4_Responses@fda.hhs.gov or mailed to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food and Drug Administration
19701 Fairchild Road
Irvine, CA 92612
Please identify your response with unique identifier CMS 615066.
If you have any questions regarding this letter, please contact William V. Millar, Compliance Officer, at (503) 671-9711 Ext. 30, or by email at firstname.lastname@example.org.
Lance M. De Souza
Acting Director, Division of Pharmaceutical Quality Operations IV
Director of Operations
Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation
Quality Control Supervisor
Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation
1 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times, most recently on February 10, 2021. This guidance communicates the Agency’s temporary policy that we do not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepare alcohol-based hand sanitizers for consumer use (or for use as health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances include preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. Your gel hand sanitizer drug products contain additional ingredients not described in the guidance and therefore are not exempted.
2 FDA is concerned that OTC hand sanitizer drug products packaged in containers that resemble drink containers commonly used by adults and children may confuse or mislead consumers and, thereby, increase the risk of accidental ingestion. Please refer to the August 27, 2020, news release titled, “COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers,” see https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-warns-consumers-about-hand-sanitizer-packaged-food-and-drink-containers, that warns consumers about alcohol-based hand sanitizers packaged in containers that resemble food or drink containers customarily purchased by U.S. consumers may put consumers at risk of serious injury or death if ingested.