FDA And EU Regulators Find Data Integrity Lapses Are Still A Major GMP Problem

The large number of US FDA warning letters going to firms for data integrity failings is mirroring trends with EU regulatory authorities, who are flagging data integrity failings in almost half of their GMP non-compliance reports. The issue strikes close to home for one FDA official.

digital hacker

Data integrity failures continue to plague the pharmaceutical industry, casting doubt on product quality years after global regulatory authorities began cracking down on the problem, a US FDA official’s recent analysis of US and EU enforcement actions shows.

The problem is personal for the FDA compliance official, who had to make a potentially life altering decision with a drug product he picked up at a pharmacy after he...

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