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...]
THE FDA AND TurboEIR – HOW IT’S MANAGED AND MISMANAGED FORM FDA 483s
TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR). It was completely “rolled out†in October 2002. For each “Objectionable Condition†(FDA 483 Observation), TurboEIR requests the inspection team to choose a … [Read more...]
HAMELN PHARMACEUTICALS, HAMELN, GERMANY RECEIVES WARNING LETTER (12/17/12)
IN-HOUSE STERILITY TESTING METHOD NOT EQUIVALENT TO USP<71> During the time frame of June 4 - 14, 2012, the Hameln facility was audited by the FDA. Following the audit, the firm responded on July 4, August 2 and 31, and September 8, 2012. Even with all of these responses, the FDA found that the firm lacked sufficient corrective actions. For … [Read more...]
