# FDA 483 - International Sterilization Laboratory, LLC - October 10, 2019

Source: https://www.globalkeysolutions.net/records/483/international-sterilization-laboratory-llc/f57e9ca4-b6fb-4cba-b467-a16c5206bf4c

> FDA 483 for International Sterilization Laboratory, LLC on October 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Sterilization Laboratory, LLC
- Inspection Date: 2019-10-10
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of International Sterilization Laboratory, LLC, a medical device contract sterilizer in Groveland, FL, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow CAPA processes, including proper identification, documentation, and effectiveness verification of corrective actions. This indicates a fundamental breakdown in their quality system for addressing nonconformances and complaints.

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/international-sterilization-laboratory-llc/c52ef7fb-6666-4799-814c-e88c40fa2c21

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