ASEPTIC FILLING FACILITY RECEIVES SIGNIFICANT OBSERVATIONS Jubilant HollisterStier located in Kirkland, Quebec, Canada was audited by the FDA on March 19-26, 2012. Following the receipt of the Form FDA 483, the Company responded on April 13, 2012 to the Observations and subsequently on May 1, June 1, and August 9, 2012. The various violations caused the drug products to be … [Read more...]
PHARMACEUTICAL COMPANY JELFA SA (POLAND) RECEIVES WARNING LETTER (7/14/11) PART II
JELFA SA FAILS TO FOLLOW FDA'S ASEPTIC PROCESSING GUIDANCE FOR INDUSTRY (SEPTEMBER 2004)  2. Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. For … [Read more...]
