Kinbio LTD
Form 483 issued May 26, 2022 · Rehovot, Israel
- Inspection
- May 15 – May 26, 2022
- Observations
- 2
- Pages
- 2
- FEI number
- 3017791608
In short: On May 26, 2022, FDA issued a Form 483 with 2 observations to Kinbio LTD in Rehovot, Israel (FEI 3017791608) after an inspection that ran May 15 – May 26, 2022. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are unclear regarding production and process controls designed to assure that the finished drug…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Questions about this 483
What did FDA find at Kinbio LTD?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Kinbio LTD inspected by FDA?
The inspection ran May 15 – May 26, 2022, and the Form 483 is dated May 26, 2022.
How do I get the full Form 483 for Kinbio LTD?
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.