CIL Isotope Separations, LLC
Form 483 issued December 13, 2017 · Xenia, Ohio
- Inspection
- Nov 13 – Dec 13, 2017
- Investigators
- Jazmine N. Still· Lauren N. Howard
- Observations
- 12
- Pages
- 11
- FEI number
- 3008934532
In short: On December 13, 2017, FDA issued a Form 483 with 12 observations to CIL Isotope Separations, LLC in Xenia, Ohio (FEI 3008934532) after an inspection that ran Nov 13 – Dec 13, 2017. The investigators were Jazmine N. Still and Lauren N. Howard. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.165 (2×) · 211.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit…
- 02
Investigations into any unexplained discrepancy, including the failure of components or finished product to meet…
- 03
Your firm does not have appropriate and scientifically justified release procedures…
- 04
Controls have not been established to assure the authenticity, integrity, and security of all computerized systems…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) 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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CIL Isotope Separations, LLC?
FDA listed 12 observations on this Form 483, mostly about production, materials and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected CIL Isotope Separations, LLC?
Jazmine N. Still and Lauren N. Howard are named on this Form 483, for the inspection of Nov 13 – Dec 13, 2017. Each investigator has a profile showing what they cite most.
When was CIL Isotope Separations, LLC inspected by FDA?
The inspection ran Nov 13 – Dec 13, 2017, and the Form 483 is dated December 13, 2017.
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.