Kashiv BioSciences, LLC
Form 483 issued November 21, 2017 · Chicago, Illinois
- Inspection
- Nov 7 – Nov 21, 2017
- Investigators
- Pace Lan· Tracy Denison
- Observations
- 6
- Pages
- 3
- FEI number
- 3011289655
In short: On November 21, 2017, FDA issued a Form 483 with 6 observations to Kashiv BioSciences, LLC in Chicago, Illinois (FEI 3011289655) after an inspection that ran Nov 7 – Nov 21, 2017. The investigators were Pace Lan and Tracy Denison. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality over-site is…
- 02
Laboratory procedures used for drug substance and drug product release…
- 03
Deviation investigations are…
- 04
Critical materials are not adequately controlled and re-evaluated to determine their suitability for use…
This inspection in context
Pace Lan
1 document · 2017
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kashiv BioSciences, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Kashiv BioSciences, LLC?
Pace Lan and Tracy Denison are named on this Form 483, for the inspection of Nov 7 – Nov 21, 2017. Each investigator has a profile showing what they cite most.
When was Kashiv BioSciences, LLC inspected by FDA?
The inspection ran Nov 7 – Nov 21, 2017, and the Form 483 is dated November 21, 2017.
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.