Topic: FDA warning letter
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.
Chinese companies now account for more than 50% of the global active pharmaceutical ingredient (API) market. It has more than 500 companies registered to sell in the U.S. and 10 times that many serving its own market. But many of those continue to struggle to meet international standards.
The FDA, which has been on a campaign to get Indian drugmakers to conform with its regulations, slapped Unimark Remedies with another warning letter in which it cited two of the Mumbai-based drugmaker’s plants for keeping poor records, failing to train employees properly, and unsanitary conditions.
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.
The FDA recently issued another warning letter to Noven, a standalone operating subsidiary of Japan-based Hisamitsu Pharmaceuticals, for lapses at its Miami production facility.
A new report shows international regulators were unimpressed with Pfizer’s operations at a Hospira plant in India during a recent inspection.