You are wrong if you think that finding the actual root cause suffices the purpose.
Why even after finding the actual root cause companies get warning letters?
I always read the observations in a way that company could not find the actual root cause.
But have you observed its impact on other batches that have been studied or not?
If you failed to study its impact on other batches then it is not going to help you.
If you failed to extend this study to other batches then also it's still non-compliance.
As per the Regulatory Authority firm's investigation into a quality-related complaint and out-of-specification (OOS) results was inadequate.
For example, in August 2018, the firm received a complaint for Potassium Sulfate, USP lot 36830004 due to mold contamination. Retain testing showed a “gross mold failure” that failed to meet your specification of no more than (NMT) (b)(4) in lot 36830004.
The firm also identified levels of mold in two additional lots that also failed to meet the specification.
But the firm did not initiate a formal recall with FDA notification but instead informed their clients the lots failed to meet specifications and instructed them to return or destroy the failing lots.
In addition, their retests showed pervasive mold in three lots, but they did not expand their investigation sufficiently to include other potentially impacted lots to fully address the scope of the problem.
Further, the investigation did not adequately document:
• The drug product lots produced and campaign length
• The historical review of the type of failure, product, or equipment
• Actions were taken to remediate the assigned root cause
The firm's response is found to be inadequate.
The firm proposes to improve its investigation procedures.
However, it does not commit to evaluating the impact on products manufactured from the date of the failure in March 2018 through September 2018, the date of implementation of corrective actions and preventive actions (CAPA).
In addition, their OOS investigation procedure does not include sufficient detail to ensure their quality unit (QU) conducted a thorough investigation to evaluate all lots potentially affected by an unexplained discrepancy, or to evaluate the effectiveness of implemented CAPA.
Review the investigations on your site whether these gaps are there. And take necessary actions.
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