Inf uSc ie nce
Form 483 issued July 30, 2019 · Chantilly, Virginia
- Inspection
- Jul 23 – Jul 30, 2019
- Investigator
- Sena G. Dissmeyer
- Observations
- 8
- Pages
- 5
- FEI number
- 3013352224
In short: On July 30, 2019, FDA issued a Form 483 with 8 observations to Inf uSc ie nce in Chantilly, Virginia (FEI 3013352224) after an inspection that ran Jul 23 – Jul 30, 2019. The investigator was Sena G. Dissmeyer. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 8 of 8 observations.
Most cited: 21 CFR 211.113 (4×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced beta.-lactam drugs without providing adequate segregation, cleaning of work surfaces and cleaning of…
- 02
The ISO 5 classified aseptic processing areas had visibly dirty equipment or…
- 03
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first…
- 04
Personnel did not disinfect and change gloves frequently…
This inspection in context
Sena G. Dissmeyer
20 documents · 2017–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Inf uSc ie nce?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment and production. 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 Inf uSc ie nce?
Sena G. Dissmeyer is named on this Form 483, for the inspection of Jul 23 – Jul 30, 2019. Each investigator has a profile showing what they cite most.
When was Inf uSc ie nce inspected by FDA?
The inspection ran Jul 23 – Jul 30, 2019, and the Form 483 is dated July 30, 2019.
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.