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. § 211.192]. For example, The inspection documented that (b)(4) … [Read more...]
CADILA HEALTHCARE LTD INDIA RECEIVES FDA WARNING LETTER (6/21/11)
CADILA (ZYFINE) RECEIVES SIGNIFICANT CGMP VIOLATIONS TO INCLUDE RECORDING OF MICROBIOLOGICAL PLATES AS “NIL” 1. Your firm’s laboratory records fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards [21 C.F.R. § 211.194]. For example, a. Your microbiologists reported the MA 5 and MA 6 microbiological … [Read more...]
TOP 15 BACTERIA REPRESENT 50% OF BACTERIAL ISOLATES IDENTIFIED
ACCUGENIX IDENTIFIED WHAT MICROORGANISMS REPRESENT THE OTHER 50% While having knowledge of the most frequently identified bacteria is informative, it is important to note that these Top 15 bacteria identified from manufacturing environments, as cited in the original post, only represent approximately 50% of the microbes that are identified during routine monitoring and … [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...]
FDA IGNORES CONSIDERATION OF WRITTEN RESPONSES IN DRAFTING WARNING LETTER
CEPHAZONE PHARMA'S (APRIL 25, 2011) INITIAL RESPONSE LACKS SUFFICIENT CORRECTIVE ACTION During our July 12, 2010 to August 26, 2010 inspection of your pharmaceutical manufacturing facility, Cephazone Pharma, LLC, located at 250 E Bonita Avenue, Pomona, CA, investigator(s) from the Food and Drug Administration (FDA) identified significant violations of … [Read more...]
