KRS Global Biotechnology, Inc.
Form 483 issued March 17, 2014 · Boca Raton, Florida
- Inspection
- Mar 4 – Mar 17, 2014
- Investigator
- Joanne E. King
- Observations
- 5
- Pages
- 3
- FEI number
- 3006412304
In short: On March 17, 2014, FDA issued a Form 483 with 5 observations to KRS Global Biotechnology, Inc. in Boca Raton, Florida (FEI 3006412304) after an inspection that ran Mar 4 – Mar 17, 2014. The investigator was Joanne E. King. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KRS Global Biotechnology, Inc.?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected KRS Global Biotechnology, Inc.?
Joanne E. King is named on this Form 483, for the inspection of Mar 4 – Mar 17, 2014. Each investigator has a profile showing what they cite most.
When was KRS Global Biotechnology, Inc. inspected by FDA?
The inspection ran Mar 4 – Mar 17, 2014, and the Form 483 is dated March 17, 2014.
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.