KRS Global Biotechnology, Inc.
FDA inspection history in Boca Raton, Florida, 2014 to 2019
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2016: one Form 483; 2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–19Four Form 483s and one warning letter, at Boca Raton, Florida.
- 2019The longest 483 on file: 14 observations over 11 pages at Boca Raton, Florida.
Cited most
Across all KRS Global Biotechnology observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features8
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.165(a)Testing and release for distribution3
- 21 CFR 211.192Production record review2
- 21 CFR 211.28(a)Personnel responsibilities2
The complete KRS Global Biotechnology file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Boca Raton, Florida
Four Form 483s and one warning letter · 2014 to 2019 · 28 observations
Latest: Form 483, Aug 14, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-14 | 483 Form 483 | Boca Raton, Florida | 14 | $99 |
| 2017-10-23 | 483 Form 483 | Boca Raton, Florida | 3 | $99 |
| 2016-08-31 | 483 Form 483 | Boca Raton, Florida | 6 | $99 |
| 2015-07-06 | Warning letter Warning letter | Boca Raton, Florida | — | $99 |
| 2014-03-17 | 483 Form 483 | Boca Raton, Florida | 5 | $99 |
Investigators on these documents
Ileana Barreto-Pettit (1)Jennifer L. Huntington (1)Jennifer Lalama (1)Joanne E. King (1)
FEI number 3006412304 · most recent document Aug 14, 2019
About KRS Global Biotechnology, Inc.
How many FDA Form 483s has KRS Global Biotechnology, Inc. received?
FDA Intel has 4 Form 483s on file for KRS Global Biotechnology, Inc.; the most recent is dated Aug 14, 2019.
When was KRS Global Biotechnology, Inc. last inspected by FDA?
The most recent FDA inspection document on file for KRS Global Biotechnology, Inc. is a Form 483 dated Aug 14, 2019, for the site in Boca Raton, Florida.
What did FDA cite at KRS Global Biotechnology, Inc.?
The regulations cited most in the observations on file for KRS Global Biotechnology, Inc. are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 8 times; 21 CFR 211.113(b) (Control of microbiological contamination), 3 times; 21 CFR 211.165(a) (Testing and release for distribution), 3 times.
Has KRS Global Biotechnology, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for KRS Global Biotechnology, Inc.; the most recent is dated Jul 6, 2015.