# FDA WARNING_LETTER - The Lebanon Corp., Inc. - February 24, 2012

Source: https://www.keypedia.com/records/warning_letter/the-lebanon-corp-inc/7bc2f819-9528-4668-8946-7df824802056

> FDA WARNING_LETTER for The Lebanon Corp., Inc. on February 24, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Lebanon Corp., Inc.
- Inspection Date: 2012-02-24
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: The Lebanon Corp., Inc. received an FDA Warning Letter (2012-DET-13) on May 17, 2012, following an inspection from December 19, 2011, to February 24, 2012. The inspection revealed that the firm's Honan Intraocular Pressure Reducer device was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: The firm's procedure lacked details on quality data analysis means and frequency, despite numerous receiving, in-process, and final inspection failures (1045, 661, and 12 respectively from 2007-2012).
2.  **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a))**: Procedures did not define a complaint, specify required documentation, outline follow-up activities, or define evaluation criteria for reportable events. The firm claimed no complaints, but 32 uninvestigated service reports were found.
3.  **Failure to control non-conforming product (2

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Company: https://www.keypedia.com/companies/the-lebanon-corp-inc/48a674eb-3275-43b3-909e-7fd0240f183e

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861