Topic: FDA warning letter

FDA sign

China's Zhejiang Hisoar slapped with FDA warning

The FDA has savaged China’s Zhejiang Hisoar Pharmaceutical site in Taizhou City in a warning saying the company did not routinely do microbial testing on APIs shipped to the U.S., but did routinely delete other failed impurities tests that would have kept batches from being acceptable for sale.  

Frontida gets warning letter for plant it just bought from Sun

India’s Sun Pharma has had a host of problems at some of its own manufacturing facilities in India but it just narrowly escaped another warning letter for a plant in the U.S., Instead the citation has been hung around the neck of Frontida BioPharm, which bought the plant in Philadelphia in June with big plans to expand the operation.