US FDA's Review Of Records Submitted By Foreign OTC Drug Firms Reveals GMP Problems
Turkish firm Gulsah Uretim Kozmetik Sanayi Anonim Sirketi is latest OTC manufacturer warned GMP violations based on records submitted in response to requests CDER submitted in March and April 2020.
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Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent Covid-19, the disease caused by the virus, and breakthrough products such as cancer treatments.
CDER compliance office director Donald Ashley offers a cautionary note to temper expectations for the FDA’s enforcement in the supplement sector. “We continue to warn the public about products very often sold as dietary supplements that contain hidden drugs,” he says.
UCLA professor Chris Tang says like most US businesses relying on supplies or production from outside the country, particularly from China, consumer health and beauty and personal care product companies should expect at least another year of supply disruption.