Warning Letter for Korean Manufacturer due to Poor Sterile Practices

Recommendation

25-27 June 2024
Munich, Germany

European Microbiology Conference 2024

Once again it shows that Warning Letters do not fall from the sky. Already in 2014 and 2016, the FDA had documented deviations from Good Manufacturing Practice during inspections of the Korean manufacturer Hanlim Pharm Co.

A further inspection this year documented further serious deviations in behaviour and process flow in aseptic production. For example, the aseptic equipment was prepared and set up without prior glove disinfection by the executing employee. In another case, 10 interventions were carried out on the line in 90 minutes due to bottle transport problems. To eliminate the bottle jam in the filling line, an employee leaned several times with his head and upper body over open bottles. Further, the employee did not take measures afterwards and before restarting, although there was a risk of microbiological contamination.

As a consequence, Hanlim was placed on the "Import Alert 66-40" list, i.e. even without a physical examination of the individual product, the drug can be blocked, which can remain in place until the defects and the corresponding documentation have been rectified.

In addition to inadequate aseptic processes, the FDA also came across an inadequate system of computer validation and data integrity. For example, three group leaders from the quality department alone had administrator rights and the option of modifying or deleting documents, which could lead to incomplete or manipulated data. The systems for time and data recording were also not properly administered, which allowed users to change recorded times and data at will. Even a case of backdating a test record was detected.

More information can be found on the FDA website under Inspections, Compliance, Enforcement, and Criminal Investigations.