PLZ Corp - 721140 - 06/02/2026

Delivery Method: VIA UPS Reference #: 320-26-88 Product: Drugs Recipient: Recipient Name Mr. Jigar Joshi Recipient Title Plant Manager PLZ Corp 6080 Vipond Dr. Mississauga ON L5T 2V4 Canada Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-88 June 2, 2026 Dear Mr. Joshi: Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 8, 2025 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, PLZ Corp, FEI 3001956890, at 6080 Vipond Drive, Mississauga, as well as subsequent correspondence. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request 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)). Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed 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 (21 CFR 211.84(d)(1) and 21 CFR 211.84(d)(2)). Your firm manufactured (b)(4) , an OTC (b)(4) drug product labeled to contain the active drug ingredient (b)(4) . This drug product is labeled and formulated to contain the inactive ingredient (b)(4) . (b)(4) are (b)(4) that may be found in (b)(4) . (b)(4) is a potential contaminant in (b)(4) and is a known human carcinogen when (b)(4) . 1,2 Your (b)(4) drug product, (b)(4) , is considered a higher-risk drug as it pertains to patient safety regarding (b)(4) contamination of (b)(4) due to the risk of inadvertent (b)(4) . You have not demonstrated that you appropriately tested incoming (b)(4) drug components used in the manufacture of (b)(4) drug products for identity, purity, strength, and quality. In response to our 704(a)(4) request, you originally indicated that you did not perform testing for (b)(4) in (b)(4) before release for use in drug product manufacturing. In subsequent correspondence, you indicated that you had tested and that your initial response was erroneous, but the data you provided only clarified that your (b)(4) components were tested for (b)(4) by the supplier and not by you. You failed to provide records indicating that you established the reliability of your supplier’s analyses through appropriate validation of the supplier’s test results. Although 21 CFR 211.84(d)(2) provides for some reliance on a certificate of analysis (COA) from the supplier of the component, such reliance is permissible only if the drug product manufacturer establishes the reliability of the supplier’s test results through appropriate validation of the test results at appropriate intervals. Additionally, you provided records to demonstrate you had conducted identity testing pursuant to the applicable United States Pharmacopeia (USP) test to satisfy the requirements for identity testing in 211.84(d)(1) and (2), but the testing does not conform to the current USP testing method, in that it is incomplete (i.e., lacks identification (b)(4) ). Without adequate testing, you lack scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products. We recognize that you provided additional data regarding identity and other testing of components used in other drug products you manufacture. While this demonstrates that testing was being conducted to verify your suppliers’ COAs for these components, unlike (b)(4) , we note that multiple specifications used for other components were deficient (e.g., lack of (b)(4) testing). As a manufacturer, you have a responsibility to sample, test, and examine, as appropriate, drug components before use in production to ensure acceptable specifications for identity, strength, quality, and purity are met. Because you have not performed appropriate testing that detects (b)(4) in your (b)(4) components, among other things, you failed to assure the acceptability of these drug components for use in manufacture of your drug products. In response to this letter, provide: Identity, assay and impurity test results from testing retains for all lots of (b)(4) (drug component) used in the manufacture of your drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for (b)(4) . Provide this information within 30 calendar days of the date of this letter. A description of how you will test each component lot for conformity with all appropriate written specifications for identity, purity, strength, and quality. 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 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. A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination. Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4) . Appropriate actions could include customer notifications and drug product recalls for any contaminated lots. The chemical quality control specifications you use to evaluate each incoming lot of drug component to determine acceptability for use in manufacturing. A gap analysis for specifications for drug components (active and inactive) between your current specifications and test procedures against the USP, where applicable. Based on your gap analysis, provide a comprehensive plan for conformance of your drug component specifications and testing to USP standards, where applicable. 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. 2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products are manufactured in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) did not effectively exercise its responsibility to ensure the acceptability of your drug components. For example, your QU did not ensure that your test procedures and specifications for (b)(4) are scientifically sound and appropriate (see 21 CFR 211.160(b)). The current USP (b)(4) monograph could be used to meet this requirement for (b)(4) ; however, your specifications for (b)(4) components did not include testing for assay, and multiple impurities (e.g., limits of (b)(4) ). Notably, you failed to have a specification that includes a test for the absence of (b)(4) . Your QU approved and accepted (b)(4) for use in drug manufacturing with deficient specifications. Your QU is responsible for fully exercising its authority and responsibilities, including responsibility for approving or rejecting all procedures or specifications impacting the identity, strength, quality, and purity of the drug product. 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. 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 representative batches within expiry and their related information before the QU disposition decision Quality Specifications Regarding (b)(4) (b)(4) is a USP article, whose specification can be found in the current USP (b)(4) monograph. As mentioned above, the specific test for (b)(4) is included in the (b)(4) monograph. Be advised that drugs including components, such as (b)(4) , that are recognized in the USP are generally required to meet the current applicable USP monograph under section 501(b) of the FD&C Act. FDA reviewed your specifications for (b)(4) components and they are incomplete when compared to the current USP specification. We note that the USP has recently revised its monograph for (b)(4) which includes updated technical requirements for (b)(4) testing in (b)(4) and is currently scheduled to be official in (b)(4) . No Longer Manufacture or Distribute Drug Products Containing (b)(4) In subsequent correspondence, at our request, you provided a signed statement that you discontinued the manufacture of the (b)(4) drug product that contained (b)(4) . You, as the Plant Manager for PLZ Corp.’s Mississauga Personal Care (MPC) facility located at 6080 Vipond Drive, Mississauga, Ontario (FEI 3001956890), stated “ (b)(4) is no longer an ingredient in any product made by MPC.” If you plan to resume production of drug products containing (b)(4) , notify this office in writing and include thorough documentation for (b)(4) testing. 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. 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 inspect to verify that you have completed corrective actions to any violations. Failure to address any violations may also result in the FDA refusing admission of articles manufactured at PLZ Corp, FEI 3001956890, at 6080 Vipond Drive, Mississauga into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B). 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. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3001956890 and ATTN: Nancy Espinal. Sincerely, /S/ Francis Godwin Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research __________________ 1 (b)(4) 2 (b)(4)