FDA outlines detailed CAPA Procedure in Warning Letter

An FDA Warning Letter notifies a company of regulatory violations observed during an inspection, citing specific laws and requiring corrective actions. A recent letter to Sun Pharmaceutical Industries Limited (India) details extensive CAPA measures for inadequate cleaning and maintenance of drug manufacturing equipment.

The FDA’s requirements include:

- An independent evaluation of cleaning effectiveness and equipment maintenance.
- A CAPA plan with corrective actions, timelines, and improvements to cleaning procedures.
- A summary of weaknesses in equipment cleaning lifecycle management.
- Immediate recognition and repair of equipment issues.
- Addressing any gaps identified by an external consultant.

The review must cover improvements to cleaning procedures, maintenance history, cross-contamination sources, and methods for identifying residual carryover and unknown peaks. The FDA also criticized the company's OOS investigations for lacking scientific rationale for root cause determinations. For further details, see the Warning Letter.