Root Cause Analysis resulted in FDA Warning Letter issuance

After inadequate root cause analyses at Intercos Europe S.p.A. in Italy, which led to an FDA Warning Letter in mid-August, another Warning Letter was issued just days later for a U.S. company. The FDA criticized both companies for failing to properly investigate unexplained discrepancies, determine root causes, or implement appropriate corrective measures. Additionally, neither company examined whether other batches of the same product were affected.

Key issues identified:

- Release tests showed unexpectedly high results, which were documented without further investigation, and the batches were still released.

- Investigations into issues like leaking roofs, which allowed moisture into controlled manufacturing areas, failed to establish long-term preventive actions.

- Investigations into out-of-specification (OOS) results were inconsistent and not timely, risking the quality of other batches.

The FDA found the company's responses inadequate, both in justifying their actions and in the scope of preventive measures. The FDA now demands an independent assessment of the company’s deviation investigation system, including historical reviews and an action plan for improving corrective and preventive actions (CAPA).