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...]
H and P Industries Lawsuit Ties Tainted Wipes to Twin’s Brain Damage
MSNBC Reports On On-Going Rare Bacterial Infection Stumped Experts Until News Of Contaminated Products Surfaced For nearly four years, a bacterial infection that left a Seattle-area newborn with severe brain damage while his twin brother developed normally has remained a medical mystery, traumatizing his family and stumping local and national disease experts. Myles Massey, … [Read more...]
Indian Mexican API Facilities Cited by FDA in Warning Letter
Dr. Reddy's Laboratories Found in Non-Compliance and In Receipt of an Import Ban Comment Dr Reddy's Mexico facilities were inspected between November 8-11, 2010. During the audit the FDA identified significant deviations from CGMP for the manufacture of APIs. These deviations caused the APIs to be adulterated. A response dated December 1, 2010, received by the Agency, … [Read more...]
