Overview
- 19 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-14.
At a glance
Inspections
19
Form 483s
13
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2025 – 14 Mar 2025 | Human Drugs | 483 | View 483 → |
| 16 Oct 2024 – 21 Oct 2024 | Human Drugs | Clean | |
| 21 Jun 2022 – 8 Jul 2022 | Human Drugs | 483 | View 483 → |
| 25 May 2021 – 11 Jun 2021 | Human Drugs | 483 | View 483 → |
| 9 Apr 2019 – 16 Apr 2019 | Human Drugs | WL | View 483 → |
| 20 Sep 2018 – 21 Sep 2018 | Human Drugs | Clean | |
| 18 Sep 2018 – 21 Sep 2018 | Human Drugs | 483 | View 483 → |
| 19 Jan 2018 – 24 Jan 2018 | Human Drugs | 483 | View 483 → |
| 19 Jun 2017 – 27 Jun 2017 | Human Drugs | 483 | On file |
| 1 Mar 2016 – 14 Mar 2016 | Human Drugs | 483 | View 483 → |
| 17 Nov 2014 – 11 Dec 2014 | Human Drugs | 483 | View 483 → |
| 17 Nov 2014 – 18 Nov 2014 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Mar 2025
21 CFR 211.165(e)
Test methods
Cited by Sean R Marcsisin, Syeda N Mahazabin, Michael O Idowu
14 Mar 2025
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Sean R Marcsisin, Syeda N Mahazabin, Michael O Idowu
14 Mar 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Sean R Marcsisin, Syeda N Mahazabin, Michael O Idowu
14 Mar 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Sean R Marcsisin, Syeda N Mahazabin, Michael O Idowu
8 Jul 2022
21 CFR 211.110(d)
Rejected in-process materials not quarantined
Cited by Jose M Cayuela, Saleem A Akhtar, Monika Borkowska
Investigators
FDA investigators tied to this site in the record.
Gayle S Lawson5 insp.
Junho Pak3 insp.
Michael R Klapal2 insp.
Sam Pepe2 insp.
Hala L Selby2 insp.
Lisa M Bellows2 insp.
Denise M Digiulio2 insp.
Sean R Marcsisin1 insp.
Syeda N Mahazabin1 insp.
Michael O Idowu1 insp.
Anastasia I Onuorah1 insp.
Jose M Cayuela1 insp.
Saleem A Akhtar1 insp.
Monika Borkowska1 insp.
Michele Gottshall1 insp.
Karen A Briggs1 insp.
Yvesna C Blaise1 insp.
Patric C Klotzbuecher1 insp.
Nicholas A Violand1 insp.
Anastasia I Offordile1 insp.
Bijoy Panicker1 insp.
Ko U Min1 insp.
Tiffani D Wilson1 insp.
Meena Bansal Gupta1 insp.
Stephen J Koniers1 insp.
Kendra L Brooks1 insp.
Lance M De Souza1 insp.
Anita R Michael1 insp.
Cynthia A Palmer1 insp.
Vlada Matusovsky1 insp.
Julianne C Mccullough1 insp.
Linda M Hoover1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 12x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind KVK-Tech, Inc.'s 13 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