The predominance of data integrity issues in FDA drug GMP warning letters appeared to diminish in February and March, when there was a greater focus on traditional manufacturing quality issues. Typical issues raised in 10 warning letters issued during that span include failure to validate manufacturing processes, inadequate testing to confirm that products meet specifications, and inadequate safeguards to prevent microbiological contamination.
FDA also posted Form 483 reports issued to four manufacturers in India for GMP violations and added six
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