ImClone Systems LLC
Form 483 issued March 9, 2018 · Branchburg, New Jersey
- Inspection
- Mar 5 – Mar 9, 2018
- Investigators
- Jose O. Hernandez-Guzman· Nailing Zhang· Yan Wang
- Observations
- 2
- Pages
- 2
- FEI number
- 3002889358
In short: On March 9, 2018, FDA issued a Form 483 with 2 observations to ImClone Systems LLC in Branchburg, New Jersey (FEI 3002889358) after an inspection that ran Mar 5 – Mar 9, 2018. The investigators were Jose O. Hernandez-Guzman, Nailing Zhang, Yan Wang and Yvesna Blaise. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.42 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Jose O. Hernandez-Guzman
2 documents · 2017–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Israel.
The firmImClone Systems LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ImClone Systems LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected ImClone Systems LLC?
Jose O. Hernandez-Guzman, Nailing Zhang, Yan Wang and Yvesna Blaise are named on this Form 483, for the inspection of Mar 5 – Mar 9, 2018. Each investigator has a profile showing what they cite most.
When was ImClone Systems LLC inspected by FDA?
The inspection ran Mar 5 – Mar 9, 2018, and the Form 483 is dated March 9, 2018.
How do I get the full Form 483 for ImClone Systems LLC?
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.