Kashiv BioSciences, LLC
Form 483 issued January 26, 2018 · Chicago, Illinois
- Investigator
- Merry Christie
- Observations
- 4
- Pages
- 3
- FEI number
- 3011289655
In short: On January 26, 2018, FDA issued a Form 483 with 4 observations to Kashiv BioSciences, LLC in Chicago, Illinois (FEI 3011289655). The investigator was Merry Christie. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.194 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent…
- 04
Failure to control the issuance and use of all GMP documents. 1. Raw data recording sheets…
This inspection in context
Merry Christie
2 documents · 2017–2018
Cites 211.194 (laboratory records) 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kashiv BioSciences, LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and facilities & equipment. 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?
Merry Christie is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Kashiv BioSciences, LLC inspected by FDA?
This Form 483 is dated January 26, 2018.
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.