Overview
- 16 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
16
Form 483s
11
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jan 2026 – 13 Feb 2026 | Human Drugs | 483 | View 483 → |
| 19 Aug 2024 – 28 Aug 2024 | Human Drugs | 483 | View 483 → |
| 18 Jan 2023 – 13 Feb 2023 | Human Drugs | WL | View 483 → |
| 22 Jan 2020 – 30 Jan 2020 | Human Drugs | 483 | View 483 → |
| 8 Nov 2017 – 16 Nov 2017 | Human Drugs | 483 | View 483 → |
| 13 Mar 2015 – 19 Mar 2015 | Human Drugs | 483 | View 483 → |
| 7 May 2014 – 23 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 May 2013 – 10 Jun 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Aug 2012 | Not recorded | 483 | View 483 → |
| 14 Feb 2011 | Not recorded | 483 | View 483 → |
| 30 Dec 2009 | Not recorded | WL | View 483 → |
| 19 Mar 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Feb 2026
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Walden H Lee, Truong X Nguyen, Crystal Monroy, Rowena S Nguyen, Luis P Torres, Pearl C Ozuruigbo, Nathan E Hellman, Ngozi G Offor
13 Feb 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Walden H Lee, Truong X Nguyen, Crystal Monroy, Rowena S Nguyen, Luis P Torres, Pearl C Ozuruigbo, Nathan E Hellman, Ngozi G Offor
13 Feb 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Walden H Lee, Truong X Nguyen, Crystal Monroy, Rowena S Nguyen, Luis P Torres, Pearl C Ozuruigbo, Nathan E Hellman, Ngozi G Offor
13 Feb 2026
21 CFR 211.165(e)
Test methods
Cited by Walden H Lee, Truong X Nguyen, Crystal Monroy, Rowena S Nguyen, Luis P Torres, Pearl C Ozuruigbo, Nathan E Hellman, Ngozi G Offor
13 Feb 2026
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Walden H Lee, Truong X Nguyen, Crystal Monroy, Rowena S Nguyen, Luis P Torres, Pearl C Ozuruigbo, Nathan E Hellman, Ngozi G Offor
Investigators
FDA investigators tied to this site in the record.
Uttaniti Limchumroon3 insp.
Ngozi G Offor2 insp.
Christopher R Czajka2 insp.
Sonya L Karsik2 insp.
Walden H Lee1 insp.
Truong X Nguyen1 insp.
Crystal Monroy1 insp.
Rowena S Nguyen1 insp.
Luis P Torres1 insp.
Pearl C Ozuruigbo1 insp.
Nathan E Hellman1 insp.
Ana-Maria A Plapcianu1 insp.
Amir Alavi1 insp.
Michael A Charles1 insp.
Diane R Weidley1 insp.
Marcus F Yambot1 insp.
Joshua P Wireman1 insp.
Alan P Kurtzberg1 insp.
Daniel J Roberts1 insp.
Arie Menachem1 insp.
Cassandra L Abellard1 insp.
Sonia R Peterson1 insp.
Maxyne T Lam1 insp.
John A Gonzalez1 insp.
Jamie M Du1 insp.
Carla J Lundi1 insp.
Brian P Putz1 insp.
Mark C Saale1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | 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 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | 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(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind K.C. Pharmaceuticals, Inc's 11 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