Immunomedics, Inc.
Form 483 issued August 14, 2018 · Morris Plains, New Jersey
- Inspection
- Aug 6 – Aug 14, 2018
- Investigators
- Gunther Bockhoudt· Madushini Dhannasena· Rajiv R. Srivastava
- Observations
- 4
- Pages
- 4
- FEI number
- 1000526871
In short: On August 14, 2018, FDA issued a Form 483 with 4 observations to Immunomedics, Inc. in Morris Plains, New Jersey (FEI 1000526871) after an inspection that ran Aug 6 – Aug 14, 2018. The investigators were Gunther Bockhoudt, Madushini Dhannasena, Rajiv R. Srivastava and Reyes Candau-Chacon. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to investigate critical…
- 02
There is no assurance that samples and batch records from the process validation and commercial batches…
- 03
Retesting procedure for ther…
- 04
The raw, material sampling and…
This inspection in context
Gunther Bockhoudt
3 documents · 2017–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ireland.
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 211.192
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 quality system and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Immunomedics, Inc.?
Gunther Bockhoudt, Madushini Dhannasena, Rajiv R. Srivastava and Reyes Candau-Chacon are named on this Form 483, for the inspection of Aug 6 – Aug 14, 2018. Each investigator has a profile showing what they cite most.
When was Immunomedics, Inc. inspected by FDA?
The inspection ran Aug 6 – Aug 14, 2018, and the Form 483 is dated August 14, 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.