Kashiv BioSciences, LLC
FDA inspection history in Chicago, Illinois, 2017 to 2024
- 6
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2018: one Form 483; 2019: one Form 483; 2022: two Form 483s; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Three Form 483s, at Chicago, Illinois.
- 2022–24Three Form 483s, at Chicago, Illinois.
- 2022The longest 483 on file: 8 observations over 7 pages at Chicago, Illinois.
Cited most
Across all Kashiv BioSciences observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.160General requirements5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
The complete Kashiv BioSciences file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Chicago, Illinois
Six Form 483s · 2017 to 2024 · 36 observations
Latest: Form 483, Jun 14, 2024 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-14 | 483 Form 483 | Chicago, Illinois | 6 | $99 |
| 2022-11-21 | 483 Form 483 | Chicago, Illinois | 8 | $99 |
| 2022-01-14 | 483 Form 483 | Chicago, Illinois | 5 | $99 |
| 2019-03-12 | 483 Form 483 | Chicago, Illinois | 7 | $99 |
| 2018-01-26 | 483 Form 483 | Chicago, Illinois | 4 | $99 |
| 2017-11-21 | 483 Form 483 | Chicago, Illinois | 6 | $99 |
Investigators on these documents
Rong Wang (2)Muna Algharibeh (1)Pace Lan (1)Pein Wg Steven Fong (1)Riley Myers (1)Tracy Denison (1)Merry Christie (1)Wendy G. Tan (1)
FEI number 3011289655 · most recent document Jun 14, 2024
About Kashiv BioSciences, LLC
How many FDA Form 483s has Kashiv BioSciences, LLC received?
FDA Intel has 6 Form 483s on file for Kashiv BioSciences, LLC; the most recent is dated Jun 14, 2024.
When was Kashiv BioSciences, LLC last inspected by FDA?
The most recent FDA inspection document on file for Kashiv BioSciences, LLC is a Form 483 dated Jun 14, 2024, for the site in Chicago, Illinois.
What did FDA cite at Kashiv BioSciences, LLC?
The regulations cited most in the observations on file for Kashiv BioSciences, LLC are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.