The U.S. Food and Drug Administration (FDA) inspected the following two pharmaceutical manufacturing facilities: August 25-29, 2014: Sandoz Private Limited, MIDC Plot Nos. 8-A/2 & 8-B, TTC Industrial Area, Kalwe Block, Village Dinghe, Navi Mumbai 400 708, Maharashtra, India (Kalwe facility) August 12-28, 2014: Sandoz Private Limited, Plot Nos. D31 & D32, MIDC, TTC … [Read more...]
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13) — PART II
WHEN IS PARAMETRIC RELEASE USING TERMINAL STERILIZATION NOT STERILIZATION 3. "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to … [Read more...]
