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Dear Jeanine,
I have encountered OOS when tightening of specs during mid-study. Before the change is implemented, we will evaluate if our product is able to meet the new specs. If the product cannot meet the specs, we do not implement the change immediately but will investigate the possible root cause. Two possible outcome that commonly arise from the investigation (based on our experience) in order to meet the new specs:
a) reduce product shelf life or
b) change the storage condition
However, we do not export our products to USA. It would be interesting to hear how your organization address the issue.
