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# CGMP Violations at Laboratorios Jaloma
- URL: https://www.fdaweb.com/cgmp-violations-at-laboratorios-jaloma/
- Published: 2026-06-02T12:00:00.000Z
- Updated: 2026-09-14T13:40:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161238

A 12/16-12/19/2025 FDA inspection at the Laboratorios Jaloma drug manufacturing facility in Oblatos, Guadalajara, Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations. A 5/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratorios-jaloma-sa-de-cv-725939-05222026?ref=fdaweb.com) says the specific violations were:

- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failure 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;
- failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes to master production and control records or other records; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

Based on the nature of the violations, FDA recommends that Laboratorios Jaloma engage a qualified consultant to perform a comprehensive six-system audit of its entire operation and then assist it in meeting CGMP requirements. The agency says it placed all of the company’s drugs and drug products offered for import into the U.S. on a 4/23 Import Alert.

The firm was told to correct any violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.