HUMIDITY PLAYS A KEY ROLE IN THE PACKAGING OF A DRUG PRODUCT Contract Pharmaceutical Services of Australia was audited by the FDA from October 30 through November 1, 2012. The FDA identified significant violations of cGMP for finished pharmaceuticals during the visit. Based upon these violations, the drug products were deemed to be … [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...]
