Woodbine Products Company Inc. - 729345 - 07/27/2026

Delivery Method: VIA UPS Reference #: 320-26-107 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Stephen A. Kuzyk Jr. Recipient Title Secretary Treasurer Woodbine Products Company Inc. 915 W. Smith Road Medina , OH 44256-2446 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-107 July 27, 2026 Dear Mr. Kuzyk: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Woodbine Products Company Inc., FEI 1519202, at 915 W. Smith Road, Medina, from February 9 to 13, 2026. 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 5, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigator observed specific violations including, but not limited to, the following.

1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures over-the-counter (OTC) (b)(4) drug products such as (b)(4) and ethanol- (b)(4) . You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., glycerin, propylene glycol, ethanol) used in the manufacture of your OTC (b)(4) drug products. Moreover, you used nonpharmaceutical-grade propylene glycol to manufacture your drug products. Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination You also failed to adequately test your incoming components at high risk of DEG or EG contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity before using it in manufacturing your OTC topical drug products. 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. Identity testing for glycerin and certain other high-risk drug components includes a limit test in the United States Pharmacopoeia (USP) to ensure that the component meets the relevant safety limits for DEG or EG levels. 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 ensure the acceptability of these components for use in the manufacture of your drug products. Products Containing Ethanol You manufacture multiple drugs that contain ethanol. You failed to adequately test your incoming component ethanol for methanol. Additionally, you failed to demonstrate that the component alcohol, used to manufacture your drug products, met USP monograph specifications including those for impurities (e.g., acetaldehyde, benzene). 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. In your response, you state that you tested retain samples of nine propylene glycol lots for DEG/EG contamination and that samples of three lots were not available. You also state that in the future, you will conduct all USP identity and impurity tests for propylene glycol and glycerin. Your response is inadequate because you do not provide procedural controls to demonstrate adequate identification testing of your components. Also, your response does not investigate the use of nonpharmaceutical-grade components, nor does it evaluate the impact of improperly tested components to drug products on the market. Without adequate testing, you do not have scientific evidence that the components conform to the appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before their use in production to ensure that acceptable quality parameters are met. In response to this letter, provide: A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures. A summary of the adequacy of your supplier qualification program and its selection, qualification, and disqualification provisions. The review should include a corrective action and preventive action (CAPA) plan to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures. A summary of results obtained from testing all components to evaluate the reliability of the certificate of analysis (COA) from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program. 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 revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of alcohol (ethanol), glycerin, propylene glycol, and certain additional high-risk components, we note that this includes the performance of parts A, B, and C of the USP monograph. The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing. A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains of all implicated finished drug product batches in which a retain of a high-risk drug component lot is unavailable for the presence of DEG and EG. A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination including, but not limited to, glycerin. Take prompt and appropriate actions to determine the safety of all lots of the components and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA 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. For manufactured drug products within expiry, a commitment to provide, no later than 30 calendar days from the date of this letter, results from testing retains for all lots of alcohol components, including organic impurities. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches.
2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Your firm failed to adequately validate the processes used to manufacture your OTC drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. Your firm also failed to validate your cleaning processes for non-dedicated equipment used to manufacture your OTC drug products. In your response, you state that you will conduct cleaning validation on shared equipment and process validation on three batches of each drug formulation. Your response is inadequate because you failed to provide your interim plans until your corrective actions are completed. You also did not conduct a risk assessment to evaluate the impact of manufacturing with unvalidated processes, nor did you provide an action plan to address any drug product quality or safety risk for batches already distributed to the U.S. market. Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA's guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. Furthermore, upon review of the inspectional records collected, it appears your (b)(4) is not suitable for its intended use. (b)(4) for pharmaceutical use must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts and identity of microbiological contamination in the system is integral to ensuring oversight of ongoing state of control and suitability of (b)(4) for use in manufacturing operations. In response to this letter, provide: A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle along with associated procedures. Describe your program for PPQ and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program. A timeline for performing PPQ for each of your marketed drug products. Also include an explanation how you will ensure that proper satisfactory PPQ studies are performed prior to future distribution of any drug products. A risk assessment for the distributed drug products produced without performing any process validation studies. 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 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. Appropriate improvements to your cleaning validation program with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case: o drugs with higher toxicities o drugs with higher drug potencies o drugs of lower solubility in their cleaning solvents o drugs with characteristics that make their manufacturing equipment difficult to clean o swabbing locations for areas that are most difficult to clean o maximum hold times before cleaning A description of the steps that will be taken in your change management system before introduction of new manufacturing equipment or a new product. A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment. A comprehensive, independent assessment of your (b)(4) system design, control, and maintenance to ensure the system design consistently produces (b)(4) adhering to (b)(4) USP monograph specifications and appropriate microbial limits. If gaps are identified, perform a risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
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). Your quality unit (QU) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Establishment of adequate written responsibilities and procedures applicable to the QU and to follow such written procedures (21 CFR 211.22(d)). Establishment of laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). 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)). Establishment of an appropriate 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)). Establishment of adequate batch production and control records that contain the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188). Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company's global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements. 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. In your response, you state that you will implement QU procedures. Your response is inadequate because you failed to provide your interim plans until your corrective actions are completed. You also did not conduct a risk assessment to evaluate the impact to batches already distributed to the U.S. market without adequate QU oversight. 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: A determination of whether procedures used by your firm are robust and appropriate. Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices. A complete and final review of each batch and its related information before the QU disposition decision. Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. CGMP Consultant Recommended Because you failed to correct repeat violations, 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. Cosmetics Manufactured for Distribution in the United States 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. Conclusion 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 [email protected]. Identify your response with FEI 1519202 and ATTN: Sena G. Dissmeyer. Sincerely, /S/ Francis Godwin Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research