FDA EIR - Pharmaron Manufacturing Services (US) LLC - July 27, 2016

Rhodes Technologies, an active pharmaceutical ingredient (API) manufacturer, underwent an FDA inspection at its Coventry, RI facility from July 11 to July 27, 2016. The inspection, conducted under programs for Post-Approval and API Process Inspections, identified several significant quality system deficiencies. The FDA issued a three-item Form 483 outlining these observations.

The primary violation involved the Quality Unit's failure to identify unknown contaminant peaks during residual solvent analyses for three lots of Hydrocodone Bitartrate. This oversight led to the release and subsequent market recovery of one contaminated lot, traced back to inadequate drum handling procedures. Additionally, the Quality Unit failed to thoroughly investigate out-of-specification results for microbial content during the requalification of the site's purified water system. The firm also did not adequately investigate deviations linked to its stability program.

In response to these findings, Rhodes Technologies' management committed to submitting a detailed written response to the FDA's New England District Office within 15 business days, outlining their proposed corrective and preventive actions.