Immunomedics (IMMU) - moderated Message Board

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Biotech / Medical : Immunomedics (IMMU) - moderated

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To: Labrador who wrote (48018)	12/10/2018 3:36:18 PM
From: Planeteer	7 Recommendations Recommended By bluelakes CelebrityEquity drtom1234 Oiji patlawche11 and 2 more members Read Replies (1) of 63276

It should be noted that this is not a "Warning Letter" it is a form 483 which is less impactful. I concur that it would explain Pehl's "issues" response on the CC.... it pre dates our outsourced manufacturing plans and would explain some cash burn Difference between form 483 and Warning.... You’ve just been issued a Form 483 following FDA inspection of your operations. These reported observations must be taken seriously and promptly addressed—what are the next steps? Following receipt of a 483, your organization is required to construct a response letter detailing a timeline and intended course of action to amend the deficiencies uncovered by the investigator. Your company has 15 business days from the formal date of issuance to respond to the 483. The FDA need not confirm your response, but you will find it prudent to contact the agency and confirm receipt. Depending on the severity of the issue, the FDA may return for another inspection and if the timeline has not been met or deficiencies not remediated, another 483 will be issued. In fact, 98% of Form 483 issuances are followed by another 483—this cycle could continue for months, even years. Warning Letter If your 483 responses are deemed insufficient, your company has shown a pattern of unresponsiveness, or the violation poses a direct threat to patient life, you may receive a Warning Letter. This indicates a significant breach of FDA regulations and must be addressed promptly. Response to a Warning Letter must include a point-by-point remediation plan for each problem noted by the investigator as well as preventive measures to avoid recurring issues. There is a grace period of several months to years for your company to correct the issues. Ultimately failing to demonstrate corrective action can escalate a Warning Letter to a Consent Decree—a legal agreement detailing the actions pledged by the company to remediate severe problem areas.

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