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Challenge
The FDA found that not following your procedure is a problem.
A multibillion dollar client had a supplier quality process that was not being executed, and was not aligned to regulations (21 CFR 820.50). Suppliers were not being audited at the prescribed regularity, some suppliers rated as low risk were making high risk parts, and others supplied product that did not meet current specifications. The results of an FDA inspection resulted in a Warning Letter that ultimately required third party audit certification. The organization had to react by proposing a plan to halt distribution of two product lines in order to focus on a permanent and comprehensive systemic solution.
