FDA WARNING_LETTER - PCI Synthesis - June 11, 2010

On December 2, 2010, the FDA issued a Warning Letter to PolyCarbon Industries, Inc., d.b.a. PCI Synthesis, following a May 11 to June 11, 2010 inspection of their Newburyport, MA API manufacturing facility. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Failure to investigate critical deviations/OOS results:** * An Out-of-Specification (OOS) impurity in Methscopolamine Nitrate API (lots 313001N09, 313001N10) was not investigated to determine impurity identity or impact, despite a commitment to stop distribution. The firm's justification of "regulatory status" was deemed inadequate. * An OOS for Loss of Drying (LOD) in Podophyllotoxin Crude (lot 081031) was not adequately investigated. This lot was used for three Podophyllotoxin API lots (802001N09, 802002N09, 802003N09), released based on a test intended only for clinical trial material, despite the API not being associated with an IND.