Seaway Pharma Inc. MARCS-CMS 717355 — December 01, 2025

WARNING LETTER

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• Delivery Method: VIA UPS ; Return Receipt Requested
• Product: Drugs ; Over-the-Counter Drugs

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• Recipient: Venkata R. Gogineni, Ph.D.; CEO; Seaway Pharma Inc.; 5 County Route 42; Massena, NY 13662; United States

• Issuing Office: Office of Manufacturing Quality; United States

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Warning Letter 320-26-22

December 1, 2025    

Dear Dr. Gogineni and Mr. Lingam:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Seaway Pharma Inc., FEI 3012275336, at 5 County Route 42, Massena, from May 19 to June 18, 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 July 30, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

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

1. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).

You manufacture over-the-counter (OTC) oral liquid drug products including, but not limited to, analgesics and cough and cold products marketed for infants and children.

You failed to ensure adequate quality unit (QU) oversight for release of your OTC drug products. For example, your QU failed to follow your procedure Batch Record Review and Release for Distribution, SOP No. QA-009, Revision 01, and between April 2024 and May 2025, released numerous batches of drug products for distribution prior to reviewing all test results to ensure they met specifications.  

Furthermore, your QU also failed to ensure that: 
• each batch of drug products was tested for the strength of active ingredients prior to release (21 CFR 211.165(a))
• laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a))

In your response, you state you anticipated passing results based on historical data and process validation and “only two batches left [y]our facility without receiving passing microbial results.” Your response is inadequate because you do not address how you plan to ensure your quality unit has sufficient resources to carry out its responsibilities and consistently ensure drug quality. Your response also lacks sound scientific justification with respect to routine batch manufacturing requirements for finished product testing. You also do not address the potential impact to drug products distributed within the United States that are within expiry.  

An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help in 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:
    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 An assessment of whether there are an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
• A commitment that your quality unit will review all test results for finished products prior to their release. 
• A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are justified, reviewed, and approved by your quality unit. Your change management program should also include provisions for determining change effectiveness.

2. 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)).

You failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination prior to use in manufacturing. For example, glycerin and sorbitol solution were used to manufacture your OTC oral drug products marketed for infants and children prior to obtaining results for identity testing of the components. Furthermore, you distributed finished products containing these high-risk components (e.g., glycerin, sorbitol 70%) before performing, reviewing, and approving adequate identity testing of the components.

In your response, you state, “Currently, there are no enforceable provisions in either the United States Code or the Code of Federal Regulations (CFR) regarding: 1) Defined acceptance criteria for DEG and/or EG.” We acknowledge your commitment to perform identity testing of high-risk components, including the required DEG and/or EG analysis. However, regarding your assertion that there are no enforceable provisions, identity testing is required under 21 CFR 211.84(d)(1) and specifically the limits for DEG and EG tests are specified in the United States Pharmacopeia (USP) which is enforceable under section 501(b) of the FD&C Act, 21 U.S.C. 351(b).

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. Of particular concern, lethal contamination events have taken place in drug products similar to those manufactured by Seaway Pharma Inc. 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.

In response to this letter, provide:  
• 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 certificates of analysis (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 your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
• A commitment that your quality unit will review all test results for components prior to their release for use in manufacturing.

3. 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)).

You failed to ensure adequate process validation for the OTC drug products you manufacture, including those indicated for infants and children. For example, you have not performed adequate process validation for the manufacture of your (b)(4) drug product to ensure control over batch-to-batch variability. For example:

• You failed to ensure that validation records included adequately pre-defined critical steps, such as (b)(4) of bulk suspension during filling.
• Your validation batch record documentation was incomplete and missing information, such as component lot and equipment identification.

In your response, you state you will fulfill all process validation requirements prior to manufacturing any batch. Your response is inadequate because you do not evaluate the potential effects of your failure to adequately validate your manufacturing processes on the quality and safety of all products that you released for distribution in the United States remaining within expiry.

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.

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 process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. 
• A timeline for performing appropriate process performance qualification (PPQ) for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.
· A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility. 
· Provide time frames for all corrective action and preventive action (CAPA) and whether the CAPA are resolved or in progress and the percent complete.

Responsibilities as a Contractor

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

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.

Change of Ownership at Facility

In a previous warning letter, dated May 14, 2019 (CMS #572904), FDA cited similar CGMP violations pertaining to Kingston Pharma, LLC, for the lack of quality oversight and failure to adequately validate manufacturing processes. While there was a subsequent transfer of ownership of the company, the manufacturing facility and multiple responsible officials remained the same. Repeated failures demonstrated during subsequent inspections conducted in September 2021, September 2023, and June 2025 indicate that executive management oversight and control over the manufacture of drugs are inadequate.  

Your firm was notified of persistent CGMP violations during the two subsequent regulatory meetings held with you on May 3, 2022, and May 13, 2024. While current and past owners have been notified of these violations, you continue to fail to implement quality commitments within a timely manner as demonstrated during our most recent inspection.  

Ineffective Quality System

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 and laboratory 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.

CGMP Consultant Recommended

We note that you are using consultants to assist you in meeting FDA requirements. 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. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.

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.

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 CDER-OC-OMQ-Communications@fda.hhs.gov.  Identify your response with FEI 3012275336 and ATTN: Lynnsey Renn.

Sincerely,
/s/                
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research