CIL Isotope Separations, LLC
FDA inspection history in Xenia, Ohio, 2017 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Xenia, Ohio.
- 2017The longest 483 on file: 12 observations over 11 pages at Xenia, Ohio.
- 2022One Form 483, at Xenia, Ohio.
Cited most
Across all CIL Isotope Separations observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling2
- 21 CFR 211.80General requirements2
- 21 CFR 211.100Written procedures; deviations1
The complete CIL Isotope Separations file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Xenia, Ohio
Two Form 483s · 2017 to 2022 · 15 observations
Latest: Form 483, Jan 25, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-25 | 483 Form 483 | Xenia, Ohio | 3 | $99 |
| 2017-12-13 | 483 Form 483 | Xenia, Ohio | 12 | $99 |
Investigators on these documents
Lauren N. Howard (2)Jazmine N. Still (1)Wen-Ning Sally Chan (1)
FEI number 3008934532 · most recent document Jan 25, 2022
About CIL Isotope Separations, LLC
How many FDA Form 483s has CIL Isotope Separations, LLC received?
FDA Intel has 2 Form 483s on file for CIL Isotope Separations, LLC; the most recent is dated Jan 25, 2022.
When was CIL Isotope Separations, LLC last inspected by FDA?
The most recent FDA inspection document on file for CIL Isotope Separations, LLC is a Form 483 dated Jan 25, 2022, for the site in Xenia, Ohio.
What did FDA cite at CIL Isotope Separations, LLC?
The regulations cited most in the observations on file for CIL Isotope Separations, LLC are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.46 (Ventilation, air filtration, air heating and cooling), 2 times.