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 regulatory action was observed simultaneously, the assumption was that the facilities in Hebei, China had been audited and the FDA found serious deficiencies. In doing so it banned all of its products from entering the United States.
Several months later (September 8, 2016) the FDA posted a Warning Letter which included several serious deficiencies. Among those deficiencies was Observation #3 which discussed 67 microbiological contamination non-conformances between January 1 and August 20, 2015. The FDA investigation documented that “microbiological contamination has been a persistent and unresolved problem at your firm since 2013”.
The FDA indicated that Hebei “have not definitely identified the specific root cause(s) of your microbiological contamination problems, nor have you taken appropriate corrective action and preventive actions”. The firm has, however, identified four potential causes which include:
- Contaminated (b)(4) supply due to inadequate (b)(4) controls
- Failing (b)(4) of the (b)(4) in the (b)(4) tank (b)(4) systems
- Production operator errors
- Inadequate sterilization of the supplement tanks used to store materials before they are discharged into the tanks
Observation #1 was written as a “failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards”.
The Quality Control laboratory failed to record and maintain complete data from analyses of (b)(4) API. “Prior to conducting official analyses your Quality Control laboratory performed “experimental” analyses on product batches to assess whether your API met specifications, but failed to document these “experimental” test in official laboratory records or to justify their exclusion. Investigator found the results of 2,404 high performance liquid chromatography (HPLC) injections in a folder titled “Experimental’ on instrument SZG-002-0061. Your Quality Unit indicated the “experimental” injections were being conducted in all (b)(4) chromatographic units in your Quality Control laboratory. Your management provided different explanations in an attempt to justify the practice, including “fear” that the sample results would not pass.”