COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. Enclosed are the "top fifteen" Observations. The Observations within the top fifteen usually do not change — although their frequency and ranking may vary. Please note that the frequencies of various Observations have … [Read more...]
APOTEX INC RECEIVES WARNING LETTER FOR MULTIPLE CANADIAN SITES (2/21/13) PART II
FDA INVESTIGATOR FINDS INACCURATE REPORTING OF MICROBIOLOGICAL DATA The FDA, during August and October 2012 inspected two Apotex, Inc. sites. This Blog only discusses the facilities located at 150 Signet Drive, Toronto, Canada. The U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) … [Read more...]
APOTEX INC RECEIVES WARNING LETTER FOR MULTIPLE CANADIAN SITES (2/21/13)
FIRM FAILED TO ESTABLISH AND FOLLOW PROCEDURES DESIGNED TO PREVENT MICROBIOLOGICAL CONTAMINATION (21 CFR 211.113(b)) The FDA, during August and October 2012 inspected two Apotex, Inc. sites. This Blog only discusses the facilities located at 150 Signet Drive, Toronto, Canada. The U.S. Food and Drug Administration (FDA) identified significant … [Read more...]
JUBILANT HOLLISTERSTIER RECEIVES WARNING LETTER (2/13/13)
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...]
MEDI-FARE DRUG AND HOME HEALTH CENTER, BLACKSBURG, SC RECEIVES WARNING LETTER (3/7/13)
SERIOUS DEFICIENCIES ARE NOTED IN THE PRACTICE OF PRODUCING STERILE DRUGS BACKGROUND Recently the FDA has been criticized for its management of the New England Compounding Center. The following Warning Letter represents one of the first Warning Letters that the Agency has issued in a similar area since the issue of Compounding Pharmacies has become a national … [Read more...]
