![]() ![]() Certain Risk 2 observations may be upgraded to Risk 1 Major observation (Risk 2) : Observation that may result in the production of a drug not consistently meeting its marketing authorization.Critical observation (Risk 1) : Observation describing a situation that is likely to result in a non-compliant product or a situation that may result in an immediate or latent health risk and any observation that involves fraud, misrepresentation or falsification of products or data.HC-SC-GC.ca :- Summary report of the Drug Good Manufacturing Practices (GMP) Inspection Program All Risk 3 observations could be upgraded to Risk 2. ![]() "Other" observations are not listed as such (Observations that are neither critical nor major are considered as "other" and will be assigned a Risk 3).
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