Kashiv BioSciences, LLC
Form 483 issued March 12, 2019 · Chicago, Illinois
- Inspection
- Mar 4 – Mar 12, 2019
- Investigators
- Pein Wg Steven Fong· Rong Wang
- Observations
- 7
- Pages
- 6
- FEI number
- 3011289655
In short: On March 12, 2019, FDA issued a Form 483 with 7 observations to Kashiv BioSciences, LLC in Chicago, Illinois (FEI 3011289655) after an inspection that ran Mar 4 – Mar 12, 2019. The investigators were Pein Wg Steven Fong and Rong Wang. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures and responsibilities applicable to the Quality…
- 02
Written procedures applicable to the Quality Unit…
- 03
Laboratory Methods are not…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Pein Wg Steven Fong
1 document · 2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Illinois.
The firmKashiv BioSciences, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kashiv BioSciences, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Kashiv BioSciences, LLC?
Pein Wg Steven Fong and Rong Wang are named on this Form 483, for the inspection of Mar 4 – Mar 12, 2019. Each investigator has a profile showing what they cite most.
When was Kashiv BioSciences, LLC inspected by FDA?
The inspection ran Mar 4 – Mar 12, 2019, and the Form 483 is dated March 12, 2019.
How do I get the full Form 483 for Kashiv BioSciences, 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.