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FDA Raises Tablet Contractor Validation, Aseptic Processing Concerns at Gilead

Tablet contractor process revalidation and aseptic processing of injectible AmBisome were areas of concern addressed in a warning letter from FDA’s Los Angeles District office to San Dimas, CA-based Gilead Sciences in late September....

The Combination of GMP & Unapproved Drug Problems Continues to Prompt FDA Warning Letters

Warning letters to a pair of over-the-counter (OTC) drug manufacturers just released by FDA indicate that the marketing of unapproved drugs continues to escalate the agency’s response when GMP problems are found....

J&J’s “Phantom Recall” and Communication with FDA Probed During House Hearing

Johnson & Johnson’s “phantom recall” of subpotent Motrin and its communications with FDA were focal points at a US House of Representatives Committee on Oversight and Government Reform hearing on September 30....

Congressional Committee Has More Questions for J&J’s Weldon

J&J’s CEO William Weldon has been invited to appear before the House Committee on Oversight and Government Reform to explain the contents of e-mail messages uncovered in the committee’s investigation into the company’s recall of children’s medicines earlier this year....

Ongoing FDA Concerns with Procedure Compliance, Media Fill Practices and Environmental Excursions at BMS’ Manati, PR Plant Draw Warning Letter

Findings by FDA during a mid-March inspection at Bristol-Myers Squibb’s (BMS) injectable operations in Manati, Puerto Rico of problems with procedure and media fill compliance – previously noted in 2005 and 2009 inspections – contributed to a late-August warning letter to the firm....

McNeil’s 2000–2010 Inspection Record Shows a Mixed Bag of Compliance for its PA and PR Sites

Since mid-July, FDA has made public 483s and establishment inspection (EIR) reports from 17 inspections of McNeil facilities, showing a mixed bag of compliance over the last decade....

Gemfibrozil Manufacturing Problems at Sun’s NJ Facility Among Issues Prompting FDA Warning Letter

Gemfibrozil manufacturing problems resulting in imploding sample bottles and unknown impurities and how they were responded to were central concerns highlighted in an FDA warning letter to Sun Pharmaceuticals in late August regarding inspection findings at the Indian generic drug company’s Cranbury, New Jersey facility....

Warning Letters to Two Overseas Sterile Ophthalmic Manufacturers Cite Similar Microbial Control Practices

FDA has issued warning letters to two foreign-based aseptic ophthalmic firms citing a strikingly similar litany of problems with procedures and practices designed to prevent microbial contamination....

FDA Concern with Particle Contamination and Related Investigations Resurfaces in Warning Letter to Sterile Drug Contract Manufacturer

A mid-August warning letter addressing March inspection findings at contract drug manufacturer Hyaluron highlights FDA’s ongoing concerns with particulate contamination problems and their investigation in aseptic manufacturing. The warning letter was issued to the CEO of New York-based Albany Molecular Research, Inc. (AMRI) which purchased ten-year-old Hyaluron in June after the inspection....

Complaint and Deviation Handling, Contamination Control Continue to Draw FDA Attention at Vaccine Plants

Complaint and deviation handling/reporting and contamination control – concerns that have been in the forefront of FDA attention during vaccine manufacturing inspections – were again focal points at a March/April inspection of Sanofi Pasteur’s vaccine plant in Marcy l’Etoile, France that resulted in an “untitled letter” from the agency on July 22....
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