Tag Archives: media fills

JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)

FIRM FAILS TO PERFORM MEDIA FILL PROCESS SIMULATIONS FOLLOWING MAJOR RENOVATION Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013.  The FDA reviewed the firm’s response from May 30 and noted that sufficient … Continue reading

Posted in 483, FDA Compliance, Microbiological Issues, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , | Leave a comment

PHARMACEUTICAL FIRM RECALLS NASAL SPRAY FOR POTENTIAL MICROBIAL CONTAMINATION (10/02/13)

NEPHRON PHARMACEUTICALS APPLAUDED FOR PROACTIVE STANCE Nephron Pharmaceuticals Corporation, Orlando, FL (NPC) recalled 689,568 cartons (ten lots) of Albuterol Sulfate Inhalation Solution for oral inhalation.  The recall, which was initiated by the firm and was voluntary, was caused by a “Lack … Continue reading

Posted in FDA Compliance, Recall, Regulatory Compliance | Tagged , , , , , , , | Leave a comment

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 … Continue reading

Posted in FDA Compliance, Microbiological Issues, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , , , , , | Leave a comment

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.  … Continue reading

Posted in FDA Compliance, Import Alert, Microbiological Issues, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , , | Leave a comment

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

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

Posted in FDA Compliance, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , , | Leave a comment

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

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

Posted in 483, FDA Compliance, Regulatory Compliance | Tagged , , , , , , , | Leave a comment

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

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

Posted in New Guidances for Industry, Positron Emission Tomography (PET), Regulatory Compliance | Tagged , , , , | Leave a comment

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 example,  a. During … Continue reading

Posted in FDA Compliance, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , , , | Leave a comment

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

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

Posted in FDA Compliance, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , , , | Leave a comment