Monthly Archives: July 2011

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 … Continue reading

Posted in FDA Compliance, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , , , , , , | 2 Comments

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 … Continue reading

Posted in FDA Compliance, Regulatory Compliance, Warning Letters | Tagged , , , , , , , , , , , , , , | Leave a comment

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 … Continue reading

Posted in FDA Compliance, Regulatory Compliance | Tagged , , , , , , , , , , , , | 1 Comment

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 … Continue reading

Posted in FDA Compliance, Import Ban, Warning Letters | Tagged , , , , , , , , , , | Leave a comment