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Laboratorios Jaloma S.A. de C.V., Guadalajara, Mexico – FDA Inspections

Inspection records and compliance data for Laboratorios Jaloma S.A. de C.V. in Guadalajara. 5 FDA inspections on record (2 OAI), 2 Form 483s, 3 warning letters, last inspected December 19, 2025.

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Company Profile

This profile covers Laboratorios Jaloma S.A. de C.V. based in Guadalajara, Mexico.

FDA Inspection History

FDA inspections
5
OAI
2
VAI
3
NAI
0
Form 483s
2
Warning letters
3

First inspected September 29, 2011. Last inspected December 19, 2025.

Most cited issue areas

  • Handling and Storage to Prevent Contamination2 inspections
  • Prepared for each batch, include complete information2 inspections
  • Washing and toilet facilities are deficient2 inspections

FDA inspections (5)

DateResultFDA center(s)Insp. #
December 19, 2025OAIHuman Drugs · Drug Quality Assurance1296198
December 7, 2018VAIHuman Drugs · Drug Quality Assurance1073905
September 9, 2016VAIHuman Drugs · Drug Quality Assurance989752
August 15, 2013VAIHuman Drugs · Drug Quality Assurance846649
September 29, 2011OAIHuman Drugs · Drug Quality Assurance750365
FDA documents

Form 483s (1)

  • Form 483s · December 19, 2025

Warning Letters (3)

  • Warning Letters · December 19, 2025
  • Warning Letters · July 22, 2020
  • Warning Letters · September 29, 2011
People (5)
Steven J. Lynn
Person
Francis Godwin
Person
Carla A. Norris
Person
Jose M. Cayuela
Person
Tamil Arasu
Person
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Company Information

Name

Laboratorios Jaloma S.A. de C.V.

FEI Number

3002600322

Address

Calle Aquiles Serdan No. 438, Col. Oblatos, Guadalajara, Guadalajara, Mexico

Country

Mexico

ID: 8f5465e8-00d3-4c76-8b39-91c6b169346b

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