Korean drugmaker lands US FDA warning for aseptic practices and backdated records
The US Food and Drug Administration (FDA) has issued Hanlim Pharm Co., Ltd. a warning letter following an inspection of its drug manufacturing facility in Seoul, South Korea, from January 29 to February 6, 2018.
According to the heavily redacted letter, inspectors observed a number of current good manufacturing practice (cGMP) violations on-site, including poor aseptic practices.
The investigator observed workers clearing bottle jams multiple times in a 90-minute period, occasionally leaning their heads and torsos over open bottles to do so, wrote the agency.
“They restarted the line without clearing open bottles that may have been contaminated by their interventions,” the FDA continued, adding that a similar cGMP violation was observed during a site inspection in 2014.
The letter also states that Hanlim’s staff did not document all cGMP activities at the time of performance.
“Our investigator observed a quality control analyst and laboratory team leader signing and backdating a test record. In the microbiology laboratory, we also observed an analyst recoding microbiological test results from environmental monitoring settling plates before reading the plates, as well as recording results for a previous day,” wrote the agency.
“Upon questioning by our investigator, the analyst stated the plate count data had been mistakenly omitted,” the FDA continued.
Hanlim’s computer controls were also inadequate, concluded the agency: “two of your laboratory software systems had unlocked time and date functions, which allowed users to change the recorded dates and times of analysis.”
FDA cited a similar cGMP violation regarding the firm’s computerised laboratory systems in July, 2016.
The agency requested Hanlim submit a corrective action and preventive action plan, adding: “We strongly recommend that [an external consultant]…assist your firm in meeting cGMP requirements.”
