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...]
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 … [Read more...]
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. § 211.192]. For example, The inspection documented that (b)(4) … [Read more...]
ALLURE LABS RECEIVES WARNING LETTER (5/24/11)
ALLURE LABS’ CITED FOR FAILURE TO CALCULATE MICROBIOLOGICAL DILUTION FACTOR CORRECTLY WITHIN PRODUCT LEADS TO PRODUCT FAILURE We have reviewed your firm’s response dated December 12, 2010, and note that it lacks sufficient corrective actions. We acknowledge your second written response, dated February 3, 2011, to the Form FDA 483. However, because this response was received … [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...]
