KRS Global Biotechnology, Inc.
Form 483 issued August 31, 2016 · Boca Raton, Florida
- Inspection
- Aug 22 – Aug 31, 2016
- Investigator
- Ileana Barreto-Pettit
- Observations
- 6
- Pages
- 10
- FEI number
- 3006412304
In short: On August 31, 2016, FDA issued a Form 483 with 6 observations to KRS Global Biotechnology, Inc. in Boca Raton, Florida (FEI 3006412304) after an inspection that ran Aug 22 – Aug 31, 2016. The investigator was Ileana Barreto-Pettit. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of dmg products pmp orting to be…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
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 6 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected KRS Global Biotechnology, Inc.?
Ileana Barreto-Pettit is named on this Form 483, for the inspection of Aug 22 – Aug 31, 2016. Each investigator has a profile showing what they cite most.
When was KRS Global Biotechnology, Inc. inspected by FDA?
The inspection ran Aug 22 – Aug 31, 2016, and the Form 483 is dated August 31, 2016.
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.