Objectionable Anaerobe Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active … [Read more...]
ABBEY COLOR, PHILADELPHIA, PA RECEIVES WARNING LETTER (FEBRUARY 19, 2013)
API MANUFACTURING FACILITY IS CITED FOR SEVERAL REPEAT WATER RELATED OBSERVATIONS During the time frame of March 13 to March 23, 2012 the FDA inspected Abbey Color, an active pharmaceutical ingredient (API) manufacturing facility in Philadelphia, PA. Following a detailed review of the firm’s response, dated April 12, 2012, the FDA concluded that … [Read more...]
REVIEW OF SELECTED OBSERVATIONS FROM BEN VENUE FDA 483 (5/25/11)
MEDIA FILL OBSERVATION GATHERS 8 "SUBOBSERVATIONS" COMMENT Enclosed are the initial four Subobservations from the audit surrounding the Media Fill Program. Where possible FDA's 2004 Aseptic Processing Guidance is referenced. OBSERVATION 3 The "Media Fill Program Parameters and Specifications" document #030-SOP-029, and the "Outlining Test Parameters and Specifications … [Read more...]
