FDA WARNING_LETTER - Perich, Larry M - September 09, 2008

The FDA issued a Warning Letter to Dr. Larry M. Perich of Perich Eye Center following an inspection from August 25 to September 9, 2008. The inspection assessed compliance with federal regulations for the clinical study of the (b)(4) device, IDE (b)(4), and PMA (b)(4).

The inspection revealed several violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include:

1. **Failure to conduct the investigation according to the signed agreement, investigational plan, and applicable FDA regulations (21 CFR 812.100 and 812.110(b)):** * At least twelve subjects were enrolled despite not meeting eligibility criteria (e.g., ten subjects had a worst (b)(4) or greater, two had a history of prior (b)(4) in the (b)(4)). * Protocol-required assessments were not conducted (e.g., (b)(4) results missing for 17 subjects, (b)(4) and/or (b)(4) not performed for ten subjects). * The IRB was not notified of a subject's death within five days as required by the protocol.

2. **Failure to follow the Investigator's Agreement (21 CFR