FDA investigators have observed violations in sterilisation process to
prevent microbial contamination and shortcomings in facility
management procedures along with lapses in the design of the
manufacturing plant. The same unit had come under the FDA radar in
March 2018.
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-finds-several-violations-in-aurobindo-sterile-injections-unit/articleshow/72192955.cms
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