Audit Findings Related to Incorrect Expiry Claims
Incorrect expiry claims are a major source of regulatory non-compliance in pharmaceutical inspections. Whether due to mislabeling, unsupported shelf life extensions, or stability data mismatches, such findings often result in warning letters, product recalls, or even import alerts. This tutorial explains the audit findings most frequently cited by agencies like the USFDA, EMA, and CDSCO,…
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