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News
FDA Bans Korean Company Products that Handled Manufacturing Over the Phone
The FDA has sent warning letters to three South Korean companies in three months. FDA inspectors determined that those Korean companies had no quality checks in place and were handling manufacturing decisions with its contractor by phone. The FDA has already banned all products from OTC drugmaker Seindni Co., and last week slapped the Seoul, South Korea drug company with a warning letter.
The FDA has cited two other South Korean drugmakers in recent months. Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant. A few weeks earlier, Firson was slapped with a warning letter and placed on an import alert after FDA inspectors determined that Firson had failed to demonstrate the ability of its aseptic processes to prevent microbial contamination, and there was no robust process to sterilize drugs.
https://www.fiercepharma.com/manufacturing/fda-bans-products-from-korean-company-handled-manufacturing-over-phone
Teva Announces 14K Jobs and $3B in Cost Cuts Around the Globe
Teva's layoffs and cost cuts are here, and they're far larger than reports predicted. The company announced that it would slash its headcount by 14,000, eliminating more than 25% of its worldwide workforce, which is 4,000 more than earlier thought. It plans to cut $3 billion from its annual costs, $1 billion more than analysts had discussed.
The ax will fall swiftly, with the majority of job cuts coming in 2018. Most of the affected employees will receive notice over the next 90 days. Teva manufacturing plants, R&D facilities, and offices around the world will shut down or be sold.
The company is heavily in debt and facing competition to its lead drug Copaxone and suffering from a slowdown in Teva's generics launch schedule.
https://www.fiercepharma.com/pharma/teva-s-stunning-list-cuts-targets-14k-jobs-3b-costs-and-plants-around-globe
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