FDA WARNING_LETTER - Otologics LLC - November 19, 2009

This FDA Warning Letter to Otologics LLC, dated March 16, 2010, details objectionable conditions observed during an inspection from October 26 to November 19, 2009. The inspection assessed compliance of the clinical study for the (b)(4) device with federal regulations (21 CFR Part 812 and Section 520(g) of the Act).

Violations include: 1. **Failure to maintain accurate, complete, and current records of correspondence relating to an investigation [21 CFR 812.140(b)(1)]**: Supplement 61, dated 7/29/09, incorrectly stated "no deviations from the investigational plan," despite 13 deviations at site 0011 and one each at sites 0038, 0039, 0026, 0020, and 0034. Additionally, Table 3 of Supplement 61 inaccurately represented (b)(4) test values for two subjects at site 0011, where testing was not performed. Otologics' December 8, 2009 response, citing a new SOP and planned training/audits, was deemed inadequate for preventing recurrence and ensuring data accuracy.

2. **Failure to maintain accurate, complete, and current device shipment records [21 CFR