Ginko International Shuts Down Jiangsu Production For Medical Device Manfuacturing Breaches

Via taipeitimes.com

Ginko International Co (金可國際), which makes contact lenses and lens-care solution, yesterday said that it would take about two weeks to remedy a factory shut down by Chinese regulators.

The Chinese Food and Drug Administration on Monday ordered Ginko to cease production at a plant operated by its subsidiary Jiangsu Horien Contact Lens Co Ltd (江蘇海倫隱形眼鏡) after a non-routine inspection earlier this month revealed breaches of medical device manufacturing rules.

The administration said Ginko’s most serious infraction was that its manufacturing records showed the amount of packaging material the company procured last year — including inventory left over from the previous year — to be less than what was needed to ship its products last year.

Ginko said that efforts to remedy the situation were under way at the plant and it is expected to gain regulatory approval to resume production in two to four weeks.

The company downplayed the closure, saying that it had enough inventory to fulfill orders for up to three months.

The company could also divert production from another China-based subsidiary Hydron Contact Lens Co Ltd (海昌隱形眼鏡) or from plants in Taiwan, it said.

Analysts said a prolonged disruption at Jiangsu Horien Contact Lens, which accounts for 30 percent of the company’s production capacity in China, would significantly slow its growth momentum this year.

The administration said other infractions included inadequate manufacturing recordkeeping for a line of cosmetic contact lens products, while records for sterilization products were also found to be insufficient, as the items used in each batch could not be tracked.

Ginko shares yesterday fell 1.36 percent to NT$254.5 in Taipei trading.

 

 

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