The Lebanon Corp., Inc. – FDA Warning Letter, Feb 24, 2012

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