Laboratorios Jaloma S.A. de C.V. MARCS-CMS 725939 — May 22, 2026

WARNING LETTER

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• Delivery Method: Via Electronic Mail - Return Receipt Requested
• Reference #: 320-26-78
• Product: Drugs ; Over-the-Counter Drugs

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• Recipient: Mr. Jaime Labastida; Managing Director ; Laboratorios Jaloma S.A. de C.V.; Calle Emiliano Zapata, No. 422; Oblatos; 44380 Guadalajara, Jal.; Mexico

• Issuing Office: Center for Drug Evaluation and Research (CDER); United States

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Warning Letter 320-26-78

May 22, 2026

Dear Mr. Labastida:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratorios Jaloma S.A. de C.V., FEI 3002600322, located at Calle Aquiles Serdan No. 438, Colonia Oblatos, Guadalajara, Jalisco, from December 15 to 19, 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 January 12, 2026, 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 ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

You failed to accurately document microbiology sampling and testing results for components used in your over-the-counter (OTC) drug products.

Your laboratory records did not accurately reflect activities performed. For example, your microbiologist documented the collection of routine (b)(4) samples, but after questioning, your microbiologist admitted that the samples were never actually taken. Furthermore, the microbiologist admitted to routinely performing colony counts after only (b)(4) of incubation, rather than following the required (b)(4) period specified in your procedure. Your firm affirmed this unacceptable practice to our investigators. Your firm’s actions represent a critical breakdown in your laboratory controls and undermine the integrity of your data.

In your response, you state that you have updated incubator logbooks to include entry fields for incubation start and end times, provided formal training to personnel, and will perform (b)(4) internal audits to assess effectiveness.

Your response is inadequate because it lacks a retrospective assessment to determine the validity of all data generated in your laboratory. Furthermore, your response does not include a gap analysis of your data integrity controls to identify systemic vulnerabilities that allow unauthorized modification or deletion of CGMP data. You also do not provide an evaluation of whether your management is appropriately qualified to provide adequate oversight of CGMP laboratory operations and data integrity.

The failure to record and maintain complete and accurate records of all test results and their associated parameters fundamentally compromises data reliability. Consequently, this lack of reliable data prevents the quality unit (QU) from effectively fulfilling its responsibility to ensure compliance with 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: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.

We strongly recommend that you retain an independent third-party 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. Your investigation should include:
  o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
  o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
  o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.
  o A comprehensive retrospective evaluation of the nature of the testing and manufacturing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all 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 plan. Your strategy should include:
  o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.
  o A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan are commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
  o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
  o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.
  o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating corrective and preventive action (CAPA) effectiveness after you have executed your data integrity remediation protocol.
  o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated by independent quality assurance function, along with expertise from outside entities whenever needed.
  o A status report for any of the above activities already underway or completed.

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 adequately validate your alternative microbial methods used to test drug products to assure the methods were equivalent to or better than United States Pharmacopeia (USP) methods.

Specifically, the (b)(4) methods your firm uses for microbial analysis of (b)(4) were deficient. Their scope was limited to testing for (b)(4), while failing to include testing for anaerobic bacteria, total yeasts and molds, or (b)(4). Additionally, the incubation times specified in your procedure were not aligned with the specifications provided in USP <61> for microbial enumeration. Further, during the inspection, your firm stated that your microbial methods had not been validated.

In your response, you state that you discontinued use of the (b)(4) method for analysis of (b)(4) samples and updated your procedures. You also provided updated microbial methods for analysis of (b)(4) samples and training records for personnel.

Your response is inadequate because it does not provide evidence that you validated your revised methods or demonstrate they are equivalent to or better than the methods in USP chapters (b)(4). Additionally, it lacks a broader evaluation of all the microbial methods to ensure they are appropriately validated or verified and suitable for use. Further, your response does not provide a comprehensive assessment of the drug products that you manufactured using components analyzed with substandard testing methods.

Test methods must be validated to demonstrate they are suitable for their intended use, reproducible, equivalent or superior to applicable USP compendial methods, and capable of detecting the presence of objectionable microorganisms in each component or finished drug product.

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, used to analyze each lot of your components before you release to manufacturing. Provide a comparative analysis demonstrating that the methods you use have been appropriately verified (USP) or validated and are equivalent to or better than USP monograph methods (non-USP).
• Validation of your microbiological test methods, including growth promotion testing, demonstrating they are equivalent to, or better than USP compendial methods, and suitable for their intended use.

3. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Your firm lacked sufficient controls over your gas chromatography (GC) instrument used to test components in your finished drug products. Your GC laboratory instrument was not adequately qualified because you failed to validate the control software or enable audit trails, and the GC data file creation and modification dates were not accurate.

Additionally, you did not have proper controls in place to prevent the deletion or manipulation of your laboratory’s electronic raw data. During the inspection, our investigators documented several chromatograph data files that could not be located in the storage folders on your GC computer. Your firm confirmed that you did not back up the electronic data located on the GC computer.

In your response, you state that you purchased a GC software package and will validate the GC system. You also commit to strengthening data controls for computer systems and software, enabling audit trails, and routinely backing up electronic data.

Your response is inadequate because it fails to include a comprehensive impact assessment of the chromatography data that was discarded or lost from your GC computer. Your response does not explain how you ensure traceability of your CGMP electronic data files that have inaccurate time stamps and lack audit trail data. Furthermore, it does not provide a timeline for completion of your GC validation and qualification activities.

In response to this letter, provide:

• A comprehensive, independent assessment and CAPA plan for computer system security and integrity. Include a report that identifies design and control vulnerabilities, provides appropriate remediations for each of your laboratory and manufacturing computer systems, and addresses the following elements:
  o A list of all hardware that includes all equipment, both stand-alone and network, in your laboratory.
  o A list of all software configurations (both equipment software and laboratory information management system) and versions, details concerning all user privileges, and oversight responsibilities for your computerized systems. Regarding user privileges, specify user roles and associated user privileges (including the specific permissions allowed for anyone who has administrative rights) for all staff who have access to the laboratory and manufacturing computer systems, with their organizational affiliation and title. Also describe how you will ensure that staff are not given administrative rights or other permissions that may compromise data retention or reliability.
  o System security provisions including, but not limited to, whether unique usernames/passwords are always used and their confidentiality is safeguarded.
  o Detailed procedures for robust use and review of audit trail data, and the current status of audit trail implementation for each of your systems.
  o Technological improvements to increase the integration of data generated through electronic systems from stand-alone equipment (for example, balances, pH meters, (b)(4) content testing equipment).
  o A detailed summary of your procedural updates and associated training including, but not limited to, system security control to prevent unauthorized access and to ensure appropriate user role assignments, secondary review of all analyses, and other system controls.

4. 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 QU lacked adequate oversight and control over your OTC drug product manufacturing operations to ensure state of control and adherence to all quality standards.

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 QU 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.

Your firm’s quality systems are inadequate. See FDA’s guidance documents ICH Q10 Pharmaceutical Quality System, and 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/71553/download and 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:
  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 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 comprehensive independent assessment of documentation practices used throughout your laboratory operations to determine where documentation is insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.

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 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.

Cosmetics Manufactured for Distribution in the United States

In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act (21 U.S.C. 321(i)). Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act (21 U.S.C. 331(a)), it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

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.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on April 23, 2026. FDA had previously placed your firm on Import Alert 66-78 on August 3, 2020, due to violative sampling results in your (b)(4) OTC drug product.

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 Laboratorios Jaloma S.A. de C.V., Calle Aquiles Serdan No. 438, Colonia Oblatos, Guadalajara, Jalisco, Mexico, 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.

After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3002600322 and ATTN: Christopher Keating.

Sincerely,
/S/

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