Tag Archives: media fills

APOTEX INC RECEIVES WARNING LETTER FOR MULTIPLE CANADIAN SITES (2/21/13)

Posted on April 7, 2013 by

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.  … Continue reading →

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MERCK KGaA RECEIVES WARNING LETTER (12/15/11)

Posted on March 3, 2012 by

FDA INCLUDES THREE EUROPEAN FACILITIES TO INCLUDE MERCK SERONO S.A., AUBONNE, SWITZERLAND WITH MEDIA FILL ISSUES The FDA released on Wednesday, February 17, 2012 a Warning Letter that was sent to Merck KGaA on December 15, 2011.  Within the Warning Letter the FDA … Continue reading →

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BEN VENUE RECEIVES YET ANOTHER FORM FDA 483 (12/2/11)

Posted on December 6, 2011 by

TWELVE PAGE, TEN ITEM 483 COMPLEMENTS 483 ISSUED EARLIER IN 2011 Ben Venue Laboratories received a second audit by four FDA investigators from Nov 7 thru Dec 2, 2011 and received a twelve page Form FDA 483 with ten Observations.  … Continue reading →

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MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS

Posted on September 30, 2011 by

CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has just released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs.  The Comment period will be 90 days.  Please … Continue reading →

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PHARMACEUTICAL COMPANY JELFA SA (POLAND) RECEIVES WARNING LETTER (7/14/11) PART II

Posted on August 15, 2011 by

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 example,  a. During … Continue reading →

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PHARMACEUTICAL COMPANY JELFA SA (POLAND) RECEIVES WARNING LETTER (7/14/11)

Posted on August 4, 2011 by

JELFA SA DISTRIBUTES FINAL PRODUCT WITH QUESTIONABLE STERILITY 1.  Your firm has not thoroughly investigated the  failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § … Continue reading →

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