The reasons for the above observation in WL are discussed below;
1. Procedure of Market Complaint not followed.
2. None of the complaints related to the presence of particles found in Injection or potential breach of vial integrity of the Injection were assigned severe.
3. Extrinsic particles or integrity breaches could be an indicator of loss of sterility. Instead, the complaints received during the past two years were classified as minor even though some of them were determined by the client as critical complaints and could lead to serious adverse events.
4. Firm classified the above complaints as minor and no CAPA was implemented.
5. In the response firm acknowledged that complaints associated with particulate contamination, coring, and seal integrity, originally classified as minor, should have been classified as major.
6. But the firm did not provide a scientific justification or rationale for not classifying these complaints as “critical.”
7. The firm's response also failed to explain the discrepancy between the sponsor’s and the firm's own complaint risk assessment classification.
What you could understand from the above reasons & discussion?
Whether you agree to keep such critical observation in the minor category?
If the classification is wrong then obviously the actions taken on that will be in the wrong direction.
Hence the complete cycle will be in the wrong direction.
This led to getting the Warning Letter to this organization.
Review your Market Complaint SOP & check whether the complaints are classified as per their actual severity ?
Whether the procedure is followed?
Whether it needs revision?
Read Blue Ocean of Compliance, which will provide you with many insights to prevent you from many non-compliances.