CIL Isotope Separations, LLC
Form 483 issued January 25, 2022 · Xenia, Ohio
- Inspection
- Jan 21 – Jan 25, 2022
- Investigators
- Lauren N. Howard· Wen-Ning Sally Chan
- Observations
- 3
- Pages
- 6
- FEI number
- 3008934532
In short: On January 25, 2022, FDA issued a Form 483 with 3 observations to CIL Isotope Separations, LLC in Xenia, Ohio (FEI 3008934532) after an inspection that ran Jan 21 – Jan 25, 2022. The investigators were Lauren N. Howard and Wen-Ning Sally Chan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.46 (2×) · 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
Observation 1: scanned text, readable in the full document.
- 02
Differential pressure set points are not appropriately established to prevent contamination of GMP production areas…
- 03
The HVAC system is…
This inspection in context
Lauren N. Howard
14 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Ohio.
The firmCIL Isotope Separations, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CIL Isotope Separations, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected CIL Isotope Separations, LLC?
Lauren N. Howard and Wen-Ning Sally Chan are named on this Form 483, for the inspection of Jan 21 – Jan 25, 2022. Each investigator has a profile showing what they cite most.
When was CIL Isotope Separations, LLC inspected by FDA?
The inspection ran Jan 21 – Jan 25, 2022, and the Form 483 is dated January 25, 2022.
How do I get the full Form 483 for CIL Isotope Separations, 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.