FDA to Conduct Reinspection of Indonesian Device Manufacturer's Plant
The Food and Drug Administration will conduct a reinspection of Indonesian device manufacturer Sugih Instrumendo Abadi’s West Java manufacturing facility after finding violations of Current Good Manufacturing Practice requirements of the quality system regulation, it said in an Oct. 22…
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warning letter. FDA will also refuse pre-market approval applications for Class III devices from the company related to the violations, it said.