KRS Global Biotechnology, Inc.
Form 483 issued October 23, 2017 · Boca Raton, Florida
- Inspection
- Oct 16 – Oct 23, 2017
- Investigator
- Jennifer Lalama
- Observations
- 3
- Pages
- 4
- FEI number
- 3006412304
In short: On October 23, 2017, FDA issued a Form 483 with 3 observations to KRS Global Biotechnology, Inc. in Boca Raton, Florida (FEI 3006412304) after an inspection that ran Oct 16 – Oct 23, 2017. The investigator was Jennifer Lalama. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmKRS Global Biotechnology, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KRS Global Biotechnology, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected KRS Global Biotechnology, Inc.?
Jennifer Lalama is named on this Form 483, for the inspection of Oct 16 – Oct 23, 2017. Each investigator has a profile showing what they cite most.
When was KRS Global Biotechnology, Inc. inspected by FDA?
The inspection ran Oct 16 – Oct 23, 2017, and the Form 483 is dated October 23, 2017.
How do I get the full Form 483 for KRS Global Biotechnology, Inc.?
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.