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...]
INDIAN MANUFACTURING FACILITIES CONTINUE TO RECEIVE FDA REGULATORY ACTIONS
HOSPIRA'S IRUNGATTUKOTTAI FACILITY RECEIVES WARNING LETTER (052813) Recently Ranbaxy settled a $500 million lawsuit with the Dept. of Justice for selling improperly manufactured and tested drugs (see previous Blogs). More recently, Maharashtra-based Wockhardt received an Import ban (see previous Blogs to learn of what other Indian based … [Read more...]
FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012
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...]
