Kashiv BioSciences, LLC
Form 483 issued November 21, 2022 · Chicago, Illinois
- Inspection
- Nov 14 – Nov 21, 2022
- Investigator
- Muna Algharibeh
- Observations
- 8
- Pages
- 7
- FEI number
- 3011289655
In short: On November 21, 2022, FDA issued a Form 483 with 8 observations to Kashiv BioSciences, LLC in Chicago, Illinois (FEI 3011289655) after an inspection that ran Nov 14 – Nov 21, 2022. The investigator was Muna Algharibeh. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kashiv BioSciences, LLC?
FDA listed 8 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Kashiv BioSciences, LLC?
Muna Algharibeh is named on this Form 483, for the inspection of Nov 14 – Nov 21, 2022. Each investigator has a profile showing what they cite most.
When was Kashiv BioSciences, LLC inspected by FDA?
The inspection ran Nov 14 – Nov 21, 2022, and the Form 483 is dated November 21, 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.