Hebei Yuxing Bio-Engineering Co Ltd received a FDA Warning Letter (Click Here) on September 6, 2016. This Warning Letter came as a result of an audit from August 17-21, 2015 and the issuing of a subsequent Import Alert in July 2016. As has often been the situation, Hebei Yuxing Bio-Engineering was placed on the FDA’s Import Alert list on July 8, 2016. Since no other … [Read more...]
Compounding Pharmacies’ Observations Correlate With Those From Large Pharma ISO 5 Facilities
Compounding pharmacies continue to receive citations from the FDA (both Form FDA 483s and Warning Letters) for a continuing failure to meet 21 CFR 210/211 requirements. All one needs to do is visit FDA’s Electronic Reading Room to learn of the ORA audits and the subsequent citations. Even after the New England Compounding Center … [Read more...]
JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)
FIRM FAILS TO PERFORM MEDIA FILL PROCESS SIMULATIONS FOLLOWING MAJOR RENOVATION Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013. The FDA reviewed the firm’s response from May 30 and noted that sufficient corrections actions were lacking. The FDA also received additional correspondence … [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...]
SANOFI AVENTIS DEUTSCHLAND GmbH WARNING LETTER
WARNING LETTER FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. Comment 21 C.F.R. § 211.113(b) states that "appropriate written procedures, designed to prevent microbiological … [Read more...]
