IDO Pharm Co., Ltd.

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, IDO Pharm Co., Ltd., 3017021001, at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, from November 10 to 13, 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 December 4, 2025, response to our Form FDA 483 in detail.

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

1. Your firm failed to establish 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 manufacture multiple drug products labelled as (b)(4).

Inadequate (b)(4) System Validation

Your firm did not establish procedures describing the operation, cleaning, maintenance, or validation of your (b)(4) system, which is used to make a component of your drug products. Hoses were observed to contain stagnant (b)(4), and your (b)(4) tank contained visible particulate matter floating on the (b)(4) surface, including what appeared to be an insect.

In your response, you state that you conducted an immediate inspection of the insanitary conditions in your (b)(4) system, storage tanks, piping, and hoses, and took corrective actions including draining and drying the hose containing stagnant (b)(4). You state that you will establish a (b)(4) system procedure that includes cleaning frequency for tanks, draining and drying criteria for hoses, and controls to prevent stagnant (b)(4). You also state you will conduct personnel training.

Your response is inadequate because your firm continues to manufacture drug products using an unqualified (b)(4) system that has not been validated for its intended use. You also failed to address the lack of qualification and validation of your (b)(4) system.

Inadequate Process and Equipment Cleaning Validation

Your firm did not conduct process validation or equipment cleaning validation for your (b)(4) over-the-counter drug products.

In your response, you state that your firm plans to relocate your facility in April 2026 and that equipment qualification and validation activities which include manufacturing processes, method validation, and cleaning validation will be performed in parallel by July 2026. 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 at www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices for general principles and approaches that FDA considers appropriate elements of process validation.

In response to this letter please 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 (PPQ), 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.

Process performance protocols and written procedures for qualification of equipment and facilities.

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.

A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system.o A (b)(4) system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.

Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your drug products.

A detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.

A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.

The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system.

A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4), USP monograph specifications and appropriate microbial limits.

2. Your firm failed to establish 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)).

You failed to appropriately establish and validate your gas chromatographic (GC) method for assay testing of (b)(4) in your finished drug products. Also, you failed to validate your GC method for determining (b)(4) and volatile impurities in your (b)(4) raw material. In addition, you failed to test your (b)(4) raw material for the presence of (b)(4) and volatile impurities.

In your response, you state that you will discontinue using the unvalidated methods and intend to establish and validate new GC testing methods. You also state your firm will implement (b)(4) testing for your (b)(4) raw material and conduct impurity testing for every lot of (b)(4) per your updated release requirements.

Your response is inadequate because you failed to conduct a risk assessment evaluating the impact of using unvalidated methods and did not address testing of finished product retains that may have been manufactured using untested or inadequately tested raw materials.

Analytical methods must be validated to demonstrate they are suitable for their intended use and equivalent or better than applicable United States Pharmacopeia compendial methods. Verifying the accuracy, sensitivity, specificity, and reproducibility of your test methods is essential to ensuring that manufactured drug products meet established specifications for chemical and microbial attributes.

In your response to this letter please provide:

A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

A comprehensive independent assessment of your laboratory practices, procedures, and methods. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.

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) did not adequately exercise its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight of the drug products you manufacture. For example, your QU failed to ensure:

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).

Performance of routine calibrations of equipment used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).

Your firm’s quality systems are inadequate. See FDA’s guidance documents, as well as 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/71553/download and at https://www.fda.gov/media/71023/download respectively.

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.

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and 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 corrective actions and preventive actions 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.

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.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on March 31, 2026.

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 re-inspect to verify that you have completed corrective actions to any violations.

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at IDO Pharm Co., Ltd., located at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, 15616, Republic of Korea, 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. 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 3017021001 and ATTN: Yvette Johnson.