LACK OF ENVIRONMENTAL MONITORING DURING 23 MONTHS ATTRACTS FDA ATTENTION Approximately one year ago (March 12 - 20, 2012), the FDA audited the Novo Nordisk A/S facility located at Novo Alle, Bagsvaerd, Denmark. During the audit the FDA encountered significant deviations that lead to the following Warning Letter. Observation 1 states that “your firm has not established or … [Read more...]
HEMOFARM A.D., VRSAC, SERBIA, RECEIVES WARNING LETTER (6/20/12) FOR ASEPTIC PROCESSING ISSUES
EXAMINE HOW THE REVISED USP<1116> RELATES TO THESE OBSERVATIONS FIRM IS PLACED UNDER FDA IMPORT ALERT Hemofarm A.D., Vrsac, Serbia recently received a four Observation Warning Letter for unreliable environmental (to include microbiological) monitoring data. Several of the CGMP violations listed in their letter include … [Read more...]
AUROBINDO PHARMA LIMITED, UNITS III AND VI, RECEIVE WARNING LETTER (MAY 20, 2011)
 AUROBINDO PHARMA RECEIVES IMPORT BAN FOLLOWED BY WARNING LETTER  -- AN UNUSUAL SEQUENCE OF EVENTS COMMENT The receiving of an Import Ban prior to receiving a Warning Letter has not been a common occurrence. However, because of the FDA's recent and previous audits, and the lack of continuing compliance, … [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...]
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...]
