Topic: FDA warning letter
The FDA has handed down another warning letter to a Chinese drug manufacturer. This time the warning was issued to Yangzhou Hengyuan Daily Chemical Plastic located in the Hanji Industrial Park in Yangzhou.
In response to an FDA warning letter, a Brazilian drug manufacturer told the FDA it has no intention of producing over-the-counter drugs for the U.S. market.
The FDA hit Japanese drug manufacturer Nippon Fine Chemical with a warning letter for obstructing an inspection at its plant last year.
A Taiwanese API maker is in hot water with the FDA, which has issued it a warning letter after an inspection in which investigators found a foul-smelling, filthy plant with insects and layers of unidentified material on the floors of rooms that had never been cleaned.
The FDA put a Chinese biologics drugmaker on import alert and followed up with a warning letter after an inspection a year ago that found serious microbial contamination at its plant in Hebei.
Brazil’s Lima & Pergher was hit with an FDA warning letter in the wake of a February inspection that found significant violations at the company’s manufacturing facility.
The FDA posted another warning letter to Pan Pharmaceuticals that further extends an import alert issued last year, effectively keeping in place a ban on the drugmaker’s products in the U.S.
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 Biopharm said it had full knowledge of issues at a manufacturing plant in Philadelphia it recently bought from Mutual Pharmaceutical, a subsidiary of India’s Sun Pharmaceutical, that was hit with a FDA warning letter.
An FDA warning letter says that when FDA inspectors looked over the facilities of Xinxiang Tuoxin Biochemical in Xinxiang City, Henan, China, last year, they found buildings full of holes, insects flying in manufacturing areas and equipment in total disrepair.