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Data Integrity Lapses Continue To Bedevil Manufacturers

A recent compilation of FDA warning letters shows that data integrity failings continue to plague API and finished drug manufacturing sites in Asia and Europe.

Data integrity failings continue to be a common problem found in drug GMP warning letters, with a growing problem at active pharmaceutical ingredient (API) sites in India.

Seven of the nine drug GMP warning letters issued to finished drug and API manufacturers in the first five months...

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