Overview
- 13 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-11.
At a glance
Inspections
13
Form 483s
5
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jul 2024 – 11 Jul 2024 | Human Drugs | 483 | On file |
| 3 Nov 2022 | Foods & Cosmetics | Clean | |
| 17 Aug 2022 – 30 Aug 2022 | Human Drugs | 483 | View 483 → |
| 11 Dec 2018 – 19 Dec 2018 | Foods & Cosmetics | 483 | View 483 → |
| 20 Jun 2018 – 21 Jun 2018 | Human Drugs | Clean | |
| 3 Dec 2015 – 10 Dec 2015 | Human Drugs | Clean | |
| 19 Feb 2014 – 3 Mar 2014 | Human Drugs | 483 | View 483 → |
| 9 Feb 2013 – 1 Mar 2013 | Human Drugs | Clean | |
| 28 Feb 2011 | Not recorded | 483 | View 483 → |
| 8 Oct 2010 | Not recorded | Clean | |
| 2 Oct 2008 | Not recorded | Clean | |
| 21 Jun 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2022
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Ross J Grigsby, Kevin P Regan, Soyinka S Eneng
19 Dec 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ross J Grigsby, Courtney R Ingalsbe, Scott A Golladay
19 Dec 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ross J Grigsby, Courtney R Ingalsbe, Scott A Golladay
3 Mar 2014
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Sandra Sejdinovic, April L Young
28 Feb 2011
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Ivan E Reyes, April L Young
Investigators
FDA investigators tied to this site in the record.
April L Young3 insp.
Marie A Fadden3 insp.
Soyinka S Eneng2 insp.
Courtney R Ingalsbe2 insp.
Ross J Grigsby2 insp.
Rafeeq A Habeeb1 insp.
Beatrix D Hippe1 insp.
Kevin P Regan1 insp.
Scott A Golladay1 insp.
Kellie L Thommes1 insp.
Nicole C Victoria1 insp.
Anthony J Ladner1 insp.
Courtney R Tiegs1 insp.
Sandra Sejdinovic1 insp.
Ivan E Reyes1 insp.
David B Wieneke1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bora Pharmaceuticals Inc.'s 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat