Overview
- 17 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-13.
At a glance
Inspections
17
Form 483s
6
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 13 Nov 2025 | Human Drugs | 483 | View 483 → |
| 20 Jul 2021 – 28 Jul 2021 | Human Drugs | Clean | |
| 14 Jan 2019 – 25 Jan 2019 | Human Drugs | Clean | |
| 23 Feb 2017 – 6 Mar 2017 | Human Drugs | 483 | View 483 → |
| 9 Sep 2014 – 17 Sep 2014 | Human Drugs | 483 | View 483 → |
| 19 Aug 2013 – 23 Aug 2013 | Human Drugs | Clean | |
| 4 Jan 2012 | Not recorded | 483 | View 483 → |
| 5 Nov 2010 | Not recorded | Clean | |
| 12 Feb 2010 | Not recorded | 483 | View 483 → |
| 2 Feb 2009 | Not recorded | 483 | On file |
| 24 Jun 2008 | Not recorded | Clean | |
| 22 Feb 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Nov 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Taichun Qin, Darren S Brown, Tiara M Brown
13 Nov 2025
21 CFR 211.192
No written record of investigation
Cited by Taichun Qin, Darren S Brown, Tiara M Brown
6 Mar 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Uttaniti Limchumroon, Taichun Qin, Jeffrey P Raimondi
17 Sep 2014
21 CFR 211.68(b)
Computer control of master formula records
Cited by Uttaniti Limchumroon, Liming Zhang, Kelvin Cheung, Chelsea N Sealey
4 Jan 2012
21 CFR 211.67(b)
Written procedures fail to include
Cited by Uttaniti Limchumroon, Carla J Lundi
Investigators
FDA investigators tied to this site in the record.
Uttaniti Limchumroon8 insp.
Taichun Qin2 insp.
Carla J Lundi2 insp.
Kelvin X Sanders2 insp.
Darren S Brown1 insp.
Tiara M Brown1 insp.
Nicholas L Hunt1 insp.
Jeffrey P Raimondi1 insp.
Liming Zhang1 insp.
Kelvin Cheung1 insp.
Chelsea N Sealey1 insp.
Joey V Quitania1 insp.
Rochelle B Young1 insp.
Maxyne T Lam1 insp.
Greg K Keshishyan1 insp.
Steven E Porter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kindeva Drug Delivery L.P.'s 6 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