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Methods for Conducting Recall Effectiveness Checks Form

Methods for Conducting Recall Effectiveness Checks Form

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hi this is Jerry Chapman senior GMP quality expert at redika systems with some insights on drug recalls to begin with would you say a drug recall can represent the ultimate failure of a company's quality system allowing defective products out of the plant and onto the market and what can we learn by analyzing what caused products to be recalled here's a graph of data taken from fda's drug recall website showing the numbers of drug recalls over a 10-year period as wheat radical systems begin to examine the data we noticed the same recalls lifted multiple times for example in 2014 two different companies issued 265 and 273 recalls each for label Mix-Ups it appears in this raw data that there were 538 recalls for label issues that year but for trending and root cause analysis purposes this is effectively just two recalls the recall data corrected for those replicates is shown in the graph here in the lower line note the vastly different numbers lower numbers for to

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