ImCl one Systems, L.L.C
Form 483 issued November 26, 2019 · Branchbu rg, New Jersey
- Inspection
- Nov 12 – Nov 26, 2019
- Investigators
- Guerlain Ulysse· Tamil Arasu
- Observations
- 2
- Pages
- 6
- FEI number
- 3002889358
In short: On November 26, 2019, FDA issued a Form 483 with 2 observations to ImCl one Systems, L.L.C in Branchbu rg, New Jersey (FEI 3002889358) after an inspection that ran Nov 12 – Nov 26, 2019. The investigators were Guerlain Ulysse and Tamil Arasu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers…
- 02
Appropriate controls are not exercised over computers…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmImCl one Systems, L.L.C history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ImCl one Systems, L.L.C?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected ImCl one Systems, L.L.C?
Guerlain Ulysse and Tamil Arasu are named on this Form 483, for the inspection of Nov 12 – Nov 26, 2019. Each investigator has a profile showing what they cite most.
When was ImCl one Systems, L.L.C inspected by FDA?
The inspection ran Nov 12 – Nov 26, 2019, and the Form 483 is dated November 26, 2019.
How do I get the full Form 483 for ImCl one Systems, L.L.C?
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