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Warning Letter 320-26-45

February 12, 2026

Dear Mr. Ross:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, AQ USA Inc., d.b.a Ross Healthcare Inc., FEI 3015167023, at 210 S Duffner Dr., Suite A, Lynden, from July 30 to August 12, 2025. We note that Ross Healthcare Inc. (FEI #3010166452) operates a manufacturing facility in Delta, B.C., Canada that was placed on Import Alert 66-40 on November 30, 2017, due to significant CGMP violations. Evidence obtained during the inspection demonstrates that you are manufacturing the same product line at your Lynden, Washington facility that was previously produced at the Canadian facility.

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 21, 2025, response to our Form FDA 483 in detail.

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

1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms. Your firm also 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 211.165(b) & 21 CFR 211.160(b)).

Your firm manufactures drug products such as (b)(4), intended for (b)(4). You failed to conduct adequate finished product testing for each batch of your drug product. For example, you released your finished drug product (b)(4) without testing for critical microbial attributes (e.g., total count, absence of objectionable microorganisms).

Furthermore, you failed to establish scientifically sound and adequate specifications for microbial limits for your drug products. For example, we reviewed your established microbiological limits for total aerobic plate count and note that they are set (b)(4) times greater than the United States Pharmacopeia (USP) <61> Microbiological Examination Of Nonsterile Products: Microbial Enumeration Tests limit of 10² cfu.

In your response, you state that you will conduct the microbial rapid test system validation accordance with USP <1223> Validation of Alternative Microbiological Methods requirements and the manufacturer’s specifications. You also note that you will verify system suitability for the specific product type and that you will maintain comprehensive raw data documentation for all tested batches.

Your response is inadequate because it lacks sufficient detail regarding tests for each finished drug batch and fails to include a risk assessment or retrospective review of products released without appropriate testing.

Adequate microbial specifications and testing methods to detect objectionable microorganisms in the presence of each drug product must be established. Without testing each batch prior to release, you did not have scientific evidence that all (b)(4) drug product batches were free of objectionable microbial contamination.

In response to this letter, provide:

• A list of chemical and microbial specifications including test methods used to analyze each batch of your drug products before a batch 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 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 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.

2. Your firm failed to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures (21 CFR 211.80(a)).

Your firm approved “(b)(4)” for use as a component in your drug products. For example, “(b)(4)” is approximately (b)(4)% of your (b)(4) drug product. At a minimum, you must use (b)(4) (refer to USP (b)(4)) to manufacture your non-sterile drug products. (b)(4) must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.

In your response, you indicate that you will discontinue the use of “(b)(4)” and procure and use only (b)(4) that meets USP (b)(4) specifications. You also state that you will initiate contract testing of your current (b)(4) supply for microbiological and chemical quality. Your response is inadequate because you failed to address drug products currently on the market that were manufactured using “(b)(4)”.

In response to this letter, provide:

• A comprehensive, independent review of your material system including, but not limited to:
  o Evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified.
  o An assessment of all materials to determine whether they are consistently of acceptable quality.
  o A review to ensure assigned expiration or retest dates are appropriate (supported by data).
  o Adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.
  o Based on a thorough review, provide a summary of your systemic corrective action and preventive action (CAPA) plan to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.
• A detailed risk assessment for drug products currently in U.S. distribution, or within expiry, manufactured using inappropriate (b)(4). 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) 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 microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
• A summary of results from testing retain samples of all drug product batches within expiry. You should test microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an out-of-specification (OOS) result, indicate the corrective actions you will take, including notifying customers and initiating recalls.

3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm failed to test incoming raw materials including active pharmaceutical ingredients (e.g., (b)(4)) used to manufacture your drug products to determine their identity, purity, strength, and other appropriate quality attributes. You released (b)(4) USP lots into production without performing adequate acceptance testing, including identity. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of each of your component suppliers’ test analyses at appropriate intervals.

In your response, you state that you will immediately withhold all incoming lots of (b)(4) USP and other raw ingredients pending sampling, testing, and approval by the quality control unit. Your response is inadequate because you do not provide details to demonstrate that your components meet all compendial requirements (e.g., specific tests to be performed). Additionally, you do not propose testing retain samples or otherwise conducting an analysis of previously used (b)(4) USP lots as well as other drug product components to ensure that all quality attributes are met.

Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before use in production to ensure that acceptable quality parameters are met.

In response to this letter, provide:

• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components 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 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 results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
• A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.

4. 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 does not have adequate stability testing data to demonstrate that the microbiological properties of your drug products meet established specifications and that they remain acceptable for the duration of their labeled shelf lives of (b)(4). During the inspection you were unable to provide raw data for any microbiological testing conducted. In addition, your firm lacked adequate stability chambers to ensure appropriate storage conditions (e.g., temperature and humidity) for your stability samples.

In your response you state that you will draft written testing program protocols to identify all marketed products for immediate stability testing, retrieve representative samples for testing initiation, and assign interim expiry dates pending preliminary data generation.

Your response is inadequate because it fails to include sufficient details on your stability program, including how you will ensure adequate sampling and appropriate specifications. Additionally, it does not include a retrospective risk assessment for your distributed drug products that are currently on the U.S. market and within expiry. Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes throughout their assigned shelf life.

In your response to this letter, provide:

• A comprehensive, independent assessment and corrective action and preventive action 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.

5. 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)

You lacked adequate quality unit (QU) oversight for the manufacture of your drug products. For example, your QU failed to ensure the following:

• Establishment of adequate production procedures and process control to assure your drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(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(b)).
• Validation of test methods to verify their accuracy, sensitivity, specificity, and reproducibility (21 CFR 211.165(e)).

In your response, you commit to drafting and approving procedures and retraining personnel. Additionally, you commit to performing process validation, updating batch records, and validating test methods.

Your response is inadequate because you do not address how you plan to ensure that your quality unit has sufficient resources to carry out its responsibilities and consistently ensure drug quality.

You did not provide details about how you will conduct process validation. Furthermore, you did not provide revised batch production records. Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and reproducible. In addition, you did not provide sufficient evidence to demonstrate in-house methods are equivalent or superior to the USP methods.

Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. 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:
  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. Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.
• A timeline for performing process validation 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 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.

CGMP Consultant Recommended

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.

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 3015167023 and ATTN: Niketa Patel.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research