Kashiv BioSciences, LLC
Form 483 issued June 14, 2024 · Chicago, Illinois
- Observations
- 6
- Pages
- 7
- FEI number
- 3011289655
In short: On June 14, 2024, FDA issued a Form 483 with 6 observations to Kashiv BioSciences, LLC in Chicago, Illinois (FEI 3011289655). Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Quality system and materials account for 4 of 6 observations.
Most cited: 21 CFR 211.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Questions about this 483
What did FDA find at Kashiv BioSciences, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
When was Kashiv BioSciences, LLC inspected by FDA?
This Form 483 is dated June 14, 2024.
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.