INWOOD LABS ESTABLISHING IN-PROCESSING CONTROLS FOR INDOMETHACIN
Executive Summary
INWOOD LABS ESTABLISHING IN-PROCESSING CONTROLS FOR INDOMETHACIN manufacturing in response to FD-483 observations that resulted from a November-December 1993 inspection of the generic firm's Inwood, New York facility. Inwood is creating "in- processing limits, controls and specifications for production of indomethacin [75 mg] extended-release capsules" and using "new/additional manufacturing instructions," according to an April 22 warning letter to Inwood's parent firm, Forest Labs, discussing Forest's past communications with FDA.