Milbar Laboratories Receives Warning Letter (July 23, 2018) for Failure to Meet Purified Water Specifications. The U.S. Food and Drug Administration (FDA) inspected Milbar Laboratories located at 20 Commerce Street, East Haven, CT from December 7–27, 2017. On July 23, 2018 they received a Warning Letter based on their audit. Several notable Observations included those … [Read more...]
ID BIOMEDICAL CORP RECEIVES WARNING LETTER (6/12/14)
COMPANY CONTINUED TO FIND GRAM NEGATIVES IN PW WATER SYSTEM ID Biomedical Corp, a subsidiary of GSK Biologicals, located in Quebec, Canada was audited by the FDA from March 31 through April 9, 2014. The FDA Investigators documented deviations from CGMP in the manufacture of their biological drug product, Flulaval and its intermediates. Significant objectionable conditions … [Read more...]
FDA ANNOUNCES VOLUNTARY NATIONWIDE RECALL OF ALL NON-EXPIRED STERILE DRUGS FROM ABRAMS ROYAL COMPOUNDING PHARMACY (12/21/13)
MICROBIAL ADVERSE EVENT CAUSES RECALL The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable … [Read more...]
USP MICROBIAL REQUIREMENTS LACKING FOR MONOGRAPHS FOR PURIFIED WATER AND WATER FOR INJECTION
COMMENT Often during webinars and seminars, the question is raised regarding the specifications for Purified Water (PW) and Water for Injection (WFI). The USP has responded with an explanation as part of their series on Microbiological Frequently Asked Questions (FAQ). Please read below to learn more about how one should develop … [Read more...]
BACTERIA MOST OFTEN SUBMITTED FOR IDENTIFICATION TESTING DURING 2010
FREQUENTLY ENCOUNTERED BACTERIAL ENVIRONMENTAL ISOLATES Microbiological consulting professionals  are often requested to assist Clients with the identification of various environmental microorganisms to include bacteria that are isolated from their various HVAC and Utility Systems during facility commissioning and on-going operations. These … [Read more...]
