Found someone apdn can help...maybe this helps push the envelope
By Anna Edney
(Bloomberg) -- U.S. regulators warned Fresenius SE after
the company’s Indian plant that makes cancer-drug ingredients
for the U.S. market aborted hundreds of drug-quality tests
because they seemed like they were going to fail due to
impurities.
When workers at the plant found potential tainted products,
they halted the tests and said human or machine errors were to
blame instead, according to a Food and Drug Administration
warning letter dated Dec. 4 that cited 248 aborted checks at the
West Bengal facility.
“It is essential that you initiate an immediate and
comprehensive assessment of your company’s global manufacturing
operations to ensure that systems and processes, and ultimately,
the products manufactured, conform to FDA requirements at all
your sites,” the agency said in its letter, which was posted on
Tuesday.
The agency recommended that Fresenius hire a consultant to
help it improve its manufacturing practices. The company, based
in Bad Homburg, Germany, didn’t respond to requests seeking
comments.
The names of the ingredients involved were redacted in the
FDA letter.
Fresenius is one Europe’s biggest provider of health care.
According to documents known as “drug master files” filed in the
past with the FDA, Fresenius manufactures ingredients used in
chemotherapies to treat many kinds of cancer. The India plant
cited in the letter is run by a unit called Fresenius Kabi,
which has over 25 manufacturing facilities worldwide.
In its warning letter, the FDA asked Fresenius to review
all failed quality tests that were invalidated for products that
are meant to be sold in the U.S. and to evaluate all instances
when a test was aborted and determine the potential effect on
the quality of drug ingredients released for distribution.
The agency also warned that if the company doesn’t correct
the issues raised in the letter, FDA workers could refuse
products made at the facility admission into the U.S.
