# FDA 483 - Laboratorio de Control ARJ, S.A. de C.V. - November 20, 2025

Source: https://www.keypedia.com/records/483/laboratorio-de-control-arj-sa-de-cv/8c5ea97d-c71f-4a28-a7d2-b8d8e89d9792

> FDA 483 for Laboratorio de Control ARJ, S.A. de C.V. on November 20, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorio de Control ARJ, S.A. de C.V.
- Inspection Date: 2025-11-20
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Laboratorio de Control ARJ, S.A. de C.V., a contract testing facility in Ciudad de México, revealed significant deficiencies in laboratory controls and data integrity. Observations included a lack of concurrent documentation for microbiology data, inadequate quality oversight for environmental monitoring, and failures in aseptic technique during sterility testing. Additionally, equipment used for sterility testing was found to be poorly maintained, indicating a systemic breakdown in quality assurance practices.

## Related Officers

- [Karla Garcia](https://www.keypedia.com/people/karla-garcia/8f811fa7-8971-49a7-a9a6-8ac2b4dd24fa)
- [Nicole M. Li](https://www.keypedia.com/people/nicole-m-li/cfffdaa1-4ed3-43a3-81fc-03ddc459c564)

Company: https://www.keypedia.com/companies/laboratorio-de-control-arj-sa-de-cv/1e89d6e8-ec22-45d3-9482-50ed865b15af

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