Data Fabrication and Dual Bookkeeping as Well
Regarding the case of the health damage that occurred due to a sleep-inducing agent getting mixed in with the antifungal agent “ITRACONAZOLE Tablets” which Kobayashi Kako Co., Ltd has manufactured and sold, Fukui Prefecture, on the 9th, ordered the company to suspend its business for 116 days, the longest ever, based on the Pharmaceutical and Medical Device Act (PMD Act). They have imposed a strict punishment after seriously since while the management had been fully aware of the manufacturing conditions such as manufacturing according to a procedure manual that is different from an authorized document, creating a dual bookkeeping for on-site inspection, and fabricating quality test results, it has kept quiet about them for a long time.
Pertaining to the ITORACONAZOLE Tablets the company has manufactured and sold, out of 344 patients who took the medication, 221 people have reported health damages including the deaths of 2 patients, as of the 1st.
The Ministry of Health, Labour and Welfare, the Prefecture, and the Pharmaceutical and Medical Device Agency (PMDA) conducted an on-site inspection at the company’s factories last December.
The inspection results revealed the manufacturing conditions for the work of taking out raw ingredients, which was supposed to be conducted by a 2-person team, was conducted by 1 person due to personnel shortage, resulting in a drug substance for a sleep-inducing agent being mistakenly used for the raw ingredient that was supposed to be used.
In addition, the creation of procedure manuals according to manufacturing conditions in violation of the authorized manuals had become normalized, and they had added the wrong drug substance in the middle of the manufacturing process. It has also become apparent that they had created false records (dual bookkeeping) as a measure for on-site inspection. The fabrication of quality testing results had also been done and the investigation to determine the cause for the detection of abnormal data had not been conducted.
Manufacturing according to unauthorized procedure manual had been done since at least around 2005, and the management had been fully aware of it since the same time. The fabrication of quality test results had been done over 40 years.
The same manufacturing conditions have been confirmed with other items, and out of 500 items manufactured at 2 factories, Yachi and Seima, the ones where dual bookkeeping was created accounted for 70% and the ones manufactured according to unauthorized procedure manuals, 30%.
Fukui Prefecture determined that these manufacturing conditions were in violation of multiple regulations of the PMD Act. According to the prefectural standards, business suspension was ordered for the company’s Yachi factory for 116 days and Seima factory for 60 days. They determined that the biggest problem was that the management had not taken any improvement measures while recognizing the condition in violation with the ordinance, and imposed a strict punishment, the longest ever, going over the 110 days imposed on the former Chemo-Sero-Therapeutic Research Institute in 2016.
However, the items with high medical needs will be excluded from the business suspension order only until it no longer affects other company’s stable provision, and the items to be excluded are being considered by the prefecture.
They have also ordered compliance with the PMD Act and other related ordinances and the improvement of its business such as revising the system of manufacturing and sales, and if an improvement does not occur, resuming of shipment shall not be allowed even after the business suspension period is over.
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