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![]() In fact, it was the very first warning letter the doctor reviewed in support of this week’s guidance. D has taken the liberty of extracting one of the observations from a recently issued warning letter that reflects a violation of 820.184. Just to show the readers how serious FDA is about the DHR, Dr. ![]() DMR, DHR, QSR, and FDA, enough acronyms for you? Remember, failure to comply with any part of the QSR and the Chief Jailable Officer (CJO) will be wishing for that magic elixir to achieve a “lenitive” (look-it-up) effect, as the FDA’s response to compliance issues will be harsh. Simply stated, the DHR reflects compliance to the DMR, which is a requirement of the QSR, required by FDA. In fact, similar to the DMR, the FDA feels so strongly about the DHR the Quality System Regulation (QSR) has a stand-alone requirement for DHR content. When it comes to retaining accurate records reflecting manufacturing in accordance with the Device Master Record (DMR), having an accurate Device History Record (DHR) to reflect compliance is a salient requirement. Folks, if an event or activity is not documented in writing, it never happened in the eyes of our friends at FDA.
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