# FDA 483 - Kappa Laboratories, Inc. - April 22, 2022

Source: https://www.globalkeysolutions.net/records/483/kappa-laboratories-inc/7259bd0a-12a9-417c-bba1-77f5eff83c91

> FDA 483 for Kappa Laboratories, Inc. on April 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kappa Laboratories, Inc.
- Inspection Date: 2022-04-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Kappa Laboratories, Inc. in Miami, FL, a contract test laboratory, was cited for a significant deficiency in its laboratory controls. The inspection revealed that the firm failed to establish scientifically sound test procedures for components, specifically omitting Total Organic Carbon testing for a USP grade component used in media plate production for drug product testing. This indicates a potential risk to the quality and purity assurance of finished drug products.

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## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Special Assistant](https://www.globalkeysolutions.net/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6