# FDA 483 - The Lebanon Corporation, Inc. - June 28, 2019

Source: https://www.globalkeysolutions.net/records/483/the-lebanon-corporation-inc/7fa60200-992c-487c-aeff-e4bcf3095888

> FDA 483 for The Lebanon Corporation, Inc. on June 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Lebanon Corporation, Inc.
- Inspection Date: 2019-06-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The Lebanon Corporation, Inc. in Lebanon, IN, received a Form FDA-483 following an inspection that identified significant deficiencies. The firm's risk analysis procedures were found inadequate, failing to update risk assessments with identified hazards and showing inconsistencies in severity and probability scores. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, with no documentation of malfunction reportability assessments for reviewed complaints.

## Related Officers

- [Debara R. Reese](https://www.globalkeysolutions.net/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.globalkeysolutions.net/companies/the-lebanon-corporation-inc/0c57b625-784c-490b-aef0-0b12b49be14f

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0