# FDA 483 - Laboratorios Jaloma S.A. de C.V. - December 19, 2025

Source: https://www.globalkeysolutions.net/records/483/laboratorios-jaloma-sa-de-cv/7e16a019-1d39-406b-b8bd-37742c02ebe0

> FDA 483 for Laboratorios Jaloma S.A. de C.V. on December 19, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Laboratorios Jaloma S.A. de C.V.
- Inspection Date: 2025-12-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Laboratorios Jaloma S.A. de C.V., an OTC drug manufacturer in Guadalajara, Mexico, was cited for significant deficiencies in laboratory controls and data integrity during an FDA inspection. Observations included incomplete and unreliable laboratory records, unvalidated and improperly executed testing procedures, deficient Out of Specification investigations, and unvalidated computer systems used for critical testing. These issues indicate a systemic lack of control over quality assurance processes.

## Related Documents

- [WARNING_LETTER - 2011-09-29](https://www.globalkeysolutions.net/records/warning_letter/laboratorios-jaloma-sa-de-cv/31fa1469-123f-4f37-94a0-8554a871e051)
- [WARNING_LETTER - 2020-07-22](https://www.globalkeysolutions.net/records/warning_letter/laboratorios-jaloma-sa-de-cv/ee912f8a-6856-4c67-b93f-82cc6a30b457)

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.globalkeysolutions.net/companies/laboratorios-jaloma-sa-de-cv/8f5465e8-00d3-4c76-8b39-91c6b169346b

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8