# FDA 483 - Kappa Laboratories, Inc. - June 04, 2025

Source: https://www.globalkeysolutions.net/records/483/kappa-laboratories-inc/6fa4e052-762b-433f-acc2-fc2ef7abd961

> FDA 483 for Kappa Laboratories, Inc. on June 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kappa Laboratories, Inc.
- Inspection Date: 2025-06-04
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Kappa Laboratories, Inc., a contact microbiology and chemistry laboratory in Miami, revealed significant deficiencies in their quality control systems. The firm failed to adequately investigate out-of-specification results, lacked proper procedures for instrument calibration, and used uncalibrated equipment. These issues indicate a breakdown in laboratory controls and data integrity.

## Related Documents

- [483 - 2022-04-22](https://www.globalkeysolutions.net/records/483/kappa-laboratories-inc/7259bd0a-12a9-417c-bba1-77f5eff83c91)

## Related Officers

- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Mickell Smith](https://www.globalkeysolutions.net/people/mickell-smith/ef92e41a-a16b-488a-a217-b10b54bb4f73)

Company: https://www.globalkeysolutions.net/companies/kappa-laboratories-inc/f57ed33f-b9d5-485c-a477-8fd51684e2ee

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9