KRS Global Biotechnology, Inc.
Form 483 issued August 14, 2019 · Boca Raton, Florida
- Inspection
- Jul 30 – Aug 14, 2019
- Investigator
- Jennifer L. Huntington
- Observations
- 14
- Pages
- 11
- FEI number
- 3006412304
In short: On August 14, 2019, FDA issued a Form 483 with 14 observations to KRS Global Biotechnology, Inc. in Boca Raton, Florida (FEI 3006412304) after an inspection that ran Jul 30 – Aug 14, 2019. The investigator was Jennifer L. Huntington. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, mug…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KRS Global Biotechnology, Inc.?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, quality system 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.?
Jennifer L. Huntington is named on this Form 483, for the inspection of Jul 30 – Aug 14, 2019. Each investigator has a profile showing what they cite most.
When was KRS Global Biotechnology, Inc. inspected by FDA?
The inspection ran Jul 30 – Aug 14, 2019, and the Form 483 is dated August 14, 2019.
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.