Immunomedics, Inc.
Form 483 issued August 1, 2018 · Morr is Plains, New Jersey
- Inspection
- Jun 14 – Aug 1, 2018
- Investigator
- Peter R. Lenahan
- Observations
- 4
- Pages
- 3
- FEI number
- 1000526871
In short: On August 1, 2018, FDA issued a Form 483 with 4 observations to Immunomedics, Inc. in Morr is Plains, New Jersey (FEI 1000526871) after an inspection that ran Jun 14 – Aug 1, 2018. The investigator was Peter R. Lenahan. Most observations concern clinical (BIMO).
At a glance
3 of 4 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 0121 CFR 312.55(b)
Not all participating investigators were informed of new observations discovered by or…
- 02
Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance…
- 0321 CFR 312.6(a)
The immediate package of the investigational new drug does not bear a label with the statement…
- 0421 CFR 11
Electronic records are used, but they do not meet systems validation and audit trail requirements to…
This inspection in context
Peter R. Lenahan
1 document · 2018
Cites 11 more than any other section. Most of their documents are for sites in New Jersey.
The firmImmunomedics, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Immunomedics, Inc.?
FDA listed 4 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected Immunomedics, Inc.?
Peter R. Lenahan is named on this Form 483, for the inspection of Jun 14 – Aug 1, 2018. Each investigator has a profile showing what they cite most.
When was Immunomedics, Inc. inspected by FDA?
The inspection ran Jun 14 – Aug 1, 2018, and the Form 483 is dated August 1, 2018.
How do I get the full Form 483 for Immunomedics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.