Working With The FDA - The FDA Warning Letter Process

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Updated June 12, 2021

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Working With The FDA - Manufacturing.net

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A nice quick and easy introductory article about FDA Warning Letters.

Working With The FDA | Pharmaceutical Processing:

"According to FDA, warning letters are sent as a way of encouraging companies to voluntarily comply with industry standards and regulatory guidelines. In that regard, they are a way of establishing a public record of the agency’s conversations with members of the industries it regulates.

Generally warning letters are sent following a routine or complaint-triggered inspection. Upon completion of an inspection, investigators may issue Form FDA-483 which documents any deficiencies found at a facility. Company officials will then be able to initially respond either through an exit discussion and/or a formal written response. Agency inspectors will also draft an Establishment Inspection Report (EIR), providing more detail on inspection observations and linking them to any evidence collected from the affected firm’s facility. Once the EIR and Form 483 are reviewed by senior FDA officials, a warning letter may follow."

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