AVEVA Drug Delivery Systems, Inc. – FDA Warning Letter, Dec 4, 2009

This FDA Warning Letter, dated May 21, 2010, was issued to AVEVA Drug Delivery Systems, Inc. following an inspection from October 22, 2009, to December 4, 2009. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's December 21, 2009, response was deemed insufficient.

Key violations include: 1. **Inadequate Production and Process Controls (21 CFR § 211.10(a)):** The firm's vacuum testing for seal quality was changed without adequate demonstration of its sufficiency, and instrument test methods for a new system were under development with no implementation timeline. 2. **Insufficient Investigation of Batch Failures (21 CFR § 211.192):** * Failure to investigate Out-of-Specification (OOS) potency results for PC160 Clonidine Adhesive Laminate (Batch No. 0000037305), with the quality unit releasing the batch despite OOS results and no root cause determined. * Failure to investigate 3-5% voided areas in PC160 Clonidine TDS patches (Batch No. 0000