Jnfuscience Inc.
Form 483 issued April 25, 2018 · Eagan, Minnesota
- Inspection
- Apr 17 – Apr 25, 2018
- Investigators
- J. L. Kalu· M. K. Kalu
- Observations
- 6
- Pages
- 3
- FEI number
- 3014124903
In short: On April 25, 2018, FDA issued a Form 483 with 6 observations to Jnfuscience Inc. in Eagan, Minnesota (FEI 3014124903) after an inspection that ran Apr 17 – Apr 25, 2018. The investigators were J. L. Kalu and M. K. Kalu. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
5 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (5×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified aseptic processing areas had visibly…
- 02
Personnel moved rapidly in the vicinity of instruments, which disrupted the airflow and increased the risk…
- 03
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first…
- 04
Materials or supplies were not disinfected prior to entering…
This inspection in context
J. L. Kalu
1 document · 2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmJnfuscience Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jnfuscience Inc.?
FDA listed 6 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Jnfuscience Inc.?
J. L. Kalu and M. K. Kalu are named on this Form 483, for the inspection of Apr 17 – Apr 25, 2018. Each investigator has a profile showing what they cite most.
When was Jnfuscience Inc. inspected by FDA?
The inspection ran Apr 17 – Apr 25, 2018, and the Form 483 is dated April 25, 2018.
How do I get the full Form 483 for Jnfuscience 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.