Deficiencies in GMP Management and Voluntary Product Recall
First written in FY2017-Q1. 4 of 10 entries say "Restated". Latest entry: FY2018.
Nihon Nohyaku moved to the "Worse" side of this theme in 2016, 4 years before the typical company in this theme (2020).
The whole theme swung hardest in 2024: 3 of 6 companies on the "Worse" side.
8 other companies' latest entry also says "Mitigated".
- FY2018MitigatedAnnual report
「As a result, the allocation of costs to be borne by our group in connection with voluntary product recalls and related matters conducted by suppliers due to the GMP control deficiencies has been finally resolved.」
The amounts to be borne, including those for suppliers with whom discussions had remained ongoing, were finalized, bringing the allocation of costs related to the voluntary recalls and other matters to final resolution. - FY2019-Q1RestatedAnnual report
「Our group had recorded, as of the end of the previous consolidated fiscal year, a reasonable estimate of the amount it deemed necessary to bear in connection with voluntary product recalls and related matters conducted by suppliers of active pharmaceutical ingredients. During the first-quarter consolidated accounting period, an additional amount that was finalized was recorded as an extraordinary loss under "Product Recall-Related Expenses."」
It has been reconfirmed that the additional amount of ¥57 million finalized during the first quarter was recorded for voluntary product recall costs resulting from the GMP deficiencies. - FY2018-Q4RestatedAnnual report
「Our group had recorded, as of the end of the previous consolidated fiscal year, a reasonable estimate of the amount it deemed necessary to bear in connection with voluntary product recalls and related matters conducted by suppliers of active pharmaceutical ingredients. During the current first-quarter consolidated accounting period, an additional amount that was finalized was recorded as an extraordinary loss under "Product Recall-Related Expenses."」
It has been reconfirmed that an additional amount of ¥57 million was recorded for voluntary product recall costs resulting from the GMP deficiencies. - FY2018-Q3MitigatedAnnual report
「As a result, the allocation of costs to be borne by our group in connection with voluntary product recalls and related matters conducted by suppliers due to the GMP control deficiencies has been finally resolved.」
The amount to be borne was agreed with suppliers with whom discussions had remained ongoing, bringing the allocation of costs related to the voluntary recalls and other matters to final resolution. In addition, the additional amount of ¥57 million was recorded as product recall-related expenses. - FY2017MaterialisedAnnual report
「Our group had recorded, as of the end of the previous consolidated fiscal year, a reasonable estimate of the amount it deemed necessary to bear in connection with voluntary product recalls and related matters conducted by suppliers of active pharmaceutical ingredients. During the current consolidated fiscal year, an additional amount that was finalized was recorded as an extraordinary loss under "Product Recall-Related Expenses."」
An additional amount to be borne in connection with the voluntary product recalls resulting from the GMP deficiencies was finalized, and ¥113 million in product recall-related expenses was recorded during the current consolidated fiscal year. - FY2018-Q1RestatedAnnual report
「A GMP (Good Manufacturing Practice) compliance inspection was conducted by the Pharmaceuticals and Medical Devices Agency in connection with the manufacture of active pharmaceutical ingredients supplied by our group, and deficiencies in GMP controls were identified. As a result, suppliers of the active pharmaceutical ingredients have conducted voluntary product recalls. Regarding the allocation of costs related to the voluntary recalls and other matters, the amount to be borne has been determined with certain suppliers, including amounts newly finalized during the second quarter consolidated accounting period, while discussions with the remaining suppliers are ongoing.」
GMP deficiencies, voluntary product recalls, the finalization of part of the amounts to be borne and the continuation of discussions with the remaining suppliers have been reconfirmed. - FY2017-Q4MaterialisedAnnual report
「A GMP (Good Manufacturing Practice) compliance inspection was conducted by the Pharmaceuticals and Medical Devices Agency in connection with the manufacture of active pharmaceutical ingredients supplied by our group, and deficiencies in GMP controls were identified. As a result, suppliers of the active pharmaceutical ingredients have conducted voluntary product recalls. Regarding the allocation of costs related to the voluntary recalls and other matters, the amount to be borne has been determined with certain suppliers, including amounts newly finalized during the current second quarter consolidated accounting period, while discussions with the remaining suppliers are ongoing.」
GMP deficiencies and voluntary product recalls remain ongoing, and part of the amount to be borne, including additional amounts, was finalized during the current second quarter. - FY2017-Q3RestatedAnnual report
「The GMP control deficiencies have been remediated, and manufacturing and shipment have resumed.」
The remediation of the GMP deficiencies and the resumption of manufacturing and shipment have been reconfirmed. Discussions with certain suppliers regarding the allocation of voluntary product recall costs remain ongoing. - FY2016MaterialisedAnnual report
「Deficiencies in GMP controls were identified. As a result, suppliers of the active pharmaceutical ingredients conducted voluntary product recalls. With respect to the amount to be borne by our group in connection with the voluntary recalls and related matters, ¥1,356 million was recorded as an extraordinary loss under "Product Recall-Related Expenses," comprising ¥312 million in finalized amounts and ¥1,044 million in estimated amounts.」
GMP deficiencies and voluntary product recalls have actually occurred, and ¥1,356 million in product recall-related expenses was recorded. Manufacturing and shipment have since resumed following remediation of the deficiencies. - FY2017-Q1First statedAnnual report
「Deficiencies in GMP controls were identified. As a result, suppliers conducted voluntary product recalls. The amount to be borne by our group in connection with the suppliers' voluntary product recalls and related matters was partially determined, and ¥311 million was recorded as an extraordinary loss under "Product Recall-Related Expenses."」
GMP deficiencies, voluntary product recalls and the recognition of ¥311 million in extraordinary loss have already occurred.