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For example, the warning letter issued to Vintage Chemical stated: “The qualified consultant should also perform a comprehensive six-system audit of your entire operation for cGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with the FDA.” 29 And, as in years past, in some letters, the FDA also reminds the firm that the “use of a consultant does not relieve your firm’s obligation to comply with cGMP

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[DOI] [PubMed] [Google Scholar] 97.Mazère J., Prunier C., Barret O., Guyot M., Hommet C., Guilloteau D., Dartigues J.F., Auriacombe S., Fabrigoule C., Allard M