Inf uSc ie nce
Form 483 issued October 8, 2021 · Chantilly, Virginia
- Inspection
- Sep 27 – Oct 8, 2021
- Investigators
- Marcia D. Fields· Sena G. Dissmeyer
- Observations
- 4
- Pages
- 3
- FEI number
- 3013352224
In short: On October 8, 2021, FDA issued a Form 483 with 4 observations to Inf uSc ie nce in Chantilly, Virginia (FEI 3013352224) after an inspection that ran Sep 27 – Oct 8, 2021. The investigators were Marcia D. Fields and Sena G. Dissmeyer. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 2 systems, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
The ISO 5 classi fied aseptic processing areas had particle-gen erating and visibly…
- 02FDCA 501(a)(2)(A)
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around…
- 03
ISO-5 classified areas were not…
- 04
Media fills were not performed that closely simulate aseptic production operations incorpora ting, as appropriate, worst-case…
This inspection in context
Marcia D. Fields
1 document · 2021
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Virginia.
The firmInf uSc ie nce history
All 2 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 Inf uSc ie nce?
FDA listed 4 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 Inf uSc ie nce?
Marcia D. Fields and Sena G. Dissmeyer are named on this Form 483, for the inspection of Sep 27 – Oct 8, 2021. Each investigator has a profile showing what they cite most.
When was Inf uSc ie nce inspected by FDA?
The inspection ran Sep 27 – Oct 8, 2021, and the Form 483 is dated October 8, 2021.
How do I get the full Form 483 for Inf uSc ie nce?
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.