"This warning letter summarises significant violations of current good
manufacturing practice (CGMP) regulations for finished pharmaceuticals
...Because your methods, facilities, or controls for manufacturing,
processing, packing, or holding do not conform to CGMP, your drug
products are adulterated," the USFDA said.
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-issues-warning-to-shilpa-medicare-for-cgmp-violations-at-telangana-plant/articleshow/78979261.cms
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