Fulijaya Manufacturing SDN. BHD.

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fulijaya Manufacturing SDN. BHD., FEI 1000291174, at No. 30, Loring Makmur 13/1, Taman Makmur Industrial Estate, Kulim, Kedah, from July 14 to 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 August 6, 2025 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.

Your laboratory records lacked complete and original data to support the analyses performed. For example, our investigator asked for raw data for microbiological release and stability testing of your over-the-counter (OTC) drug products prior to May 2025 and your firm’s representative stated that the logbooks were not available.

Reliability of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with all tests. Furthermore, the lack of reliable data compromises the quality unit’s ability to exercise its function of ensuring compliance to applicable standards.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:

A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.

A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.

A management strategy for your firm that includes the details of your global corrective action and preventive action (CAPA) plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.

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)).

Your firm failed to demonstrate that your microbiological test methods were appropriate to assure your drug products and components conform to appropriate standards of quality and purity. Specifically, you failed to conduct growth promotion testing of your microbiological media to assure suitability before use in release and stability testing of your drug products. Additionally, you lacked appropriate sampling and testing to ensure (b)(4) used as a component in your drug products is suitable for its intended use as you did not perform testing for Burkholderia cepacia complex (BCC).

In your response, you acknowledged that your firm accepted media growth promotion testing solely based on the supplier’s certificate of analysis (CoA) without independent verification. You also acknowledged that your firm did not perform suitability testing and did not evaluate your (b)(4) system for BCC. Your firm committed to using a qualified third-party laboratory to verify the quality of growth media and to perform suitability testing, as well as initiate sampling and testing of your (b)(4) system for BCC. Your response is inadequate. Notably, your response stated that a review of internal microbial limit testing data from recent years indicates that microbial detection has been achievable, demonstrating the effectiveness of the current testing process. However, as noted in this letter, your internal microbial limit testing is flawed.

The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product must be established. Results generated using unverified or unvalidated methods may put consumers at risk.

In response to this letter, provide:

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

A list of chemical and microbial specifications, including test methods and date validated and/or verified, used to analyze each batch of your drug products before a batch disposition decision.o An action plan and timelines for conducting full microbiological testing of retain samples to determine the quality of all batches of drug product 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 retrospective risk assessment of prior testing to assure suitability of all growth media for the last three years of drug microbiological testing to ensure reliable microbial enumeration and appropriate identification of objectionable microorganisms.

3. Your firm failed to establish and follow an adequate 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)).

Your firm did not have adequate stability data to demonstrate that the quality attributes of your drug products remain acceptable throughout the labeled expiry period. Assay testing for each active ingredient in your drug products was not being performed at each of your pre-determined timepoint intervals. Furthermore, your firm did not establish appropriate limits for impurities or evaluate your drug products for the presence of impurities.

Your firm’s response is inadequate. You provided accelerated stability data for your drug products, but you did not include testing for all active ingredients and impurities. For example, the stability data for your (b)(4) lacked testing for one of the active ingredients, (b)(4), and impurities.

Furthermore, in a November 12, 2024 communication your firm committed to updating your stability testing procedures to require active ingredient testing. This communication was a response to a request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4).

In response to this letter, provide:

A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).

All procedures that describe these and other elements of your remediated stability program.

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as testing laboratories. FDA regards contractors as extensions of the manufacturer. For example, contract testing laboratories performing specific identity testing of drug components (e.g., the presence of (b)(4) in (b)(4) USP) must use verified USP methods.

The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide, particularly with (b)(4) drug products. Your firm should perform an assessment of all testing performed by contract laboratories to ensure that the methods being utilized have been appropriately validated and/or verified. See FDA’s guidance document (b)(4).

You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure 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.

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.

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 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 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 re-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 Fulijaya Manufacturing SDN. BHD., No. 30, Loring Makmur 13/1, Taman Makmur Industrial Estate, Kulim, Kedah, Malaysia 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 1000291174 and ATTN: Ernest Bizjak.