Free PDF · For QA, CI, and OpEx teams

The CAPA patterns FDA cites — and the rewrite that would have passed.

A working library of the language FDA writes into Warning Letters and Form 483s, paraphrased from real public actions. Each pattern shows what the firm wrote, why the inspector flagged it, what regulation it violated, and what would have landed instead.

• Operator-error root cause (with the Aspen case)
• Training-only CAPA in regulated environments (with the Lupin case)
• “Continue to monitor” effectiveness (with the Cipla case)
• Undefined targets / “industry standard” (with the Macleods case)
• Missing prior-occurrence search (with the Sun Pharma case)
• No MSA on visual inspection (with the Hospira case)
• Plus the rewrite-to-pass for each, in practitioner voice

Used internally by Taktly to grade every CAPA / RCA / DMAIC the audit reviews. Free to download — we ask for your email so we can send updates when new patterns are added (about every 2 weeks).