Kashiv BioSciences, LLC
Form 483 issued January 14, 2022 · Chicago, Illinois
- Inspection
- Jan 10 – Jan 14, 2022
- Investigators
- Riley Myers· Rong Wang· Wendy G. Tan
- Observations
- 5
- Pages
- 5
- FEI number
- 3011289655
In short: On January 14, 2022, FDA issued a Form 483 with 5 observations to Kashiv BioSciences, LLC in Chicago, Illinois (FEI 3011289655) after an inspection that ran Jan 10 – Jan 14, 2022. The investigators were Riley Myers, Rong Wang and Wendy G. Tan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to adequately investigate environmental monitoring excursions and out of…
- 02
Establishment of the reliability of the component suppliers’ report of analyses is deficient because the test…
- 03
Documentation of each significant step in the batch production records is inadequate because no time is…
- 04
Your firm failed to follow written procedures, following are some of the deficiencies, but…
This inspection in context
Riley Myers
7 documents · 2018–2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
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 5 observations on this Form 483, mostly about production, quality system and materials. 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?
Riley Myers, Rong Wang and Wendy G. Tan are named on this Form 483, for the inspection of Jan 10 – Jan 14, 2022. Each investigator has a profile showing what they cite most.
When was Kashiv BioSciences, LLC inspected by FDA?
The inspection ran Jan 10 – Jan 14, 2022, and the Form 483 is dated January 14, 2022.
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.