Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-28.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jul 2023 – 28 Jul 2023 | Human Drugs | 483 | View 483 → |
| 2 Aug 2021 – 12 Aug 2021 | Human Drugs | 483 | View 483 → |
| 9 Jul 2018 – 20 Jul 2018 | Human Drugs | WL | On file |
| 27 Feb 2017 – 2 Mar 2017 | Animal Drugs & Feeds | 483 | On file |
| 31 Aug 2015 – 4 Sep 2015 | Human Drugs | 483 | View 483 → |
| 7 Oct 2014 – 15 Oct 2014 | Human Drugs | Clean | |
| 10 Aug 2011 | Not recorded | 483 | View 483 → |
| 25 Sep 2008 | Not recorded | 483 | On file |
| 26 Aug 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Aug 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jared P Stevens, Bonita S Chester
12 Aug 2021
21 CFR 211.111
Establishment of time limitations
Cited by Jared P Stevens, Bonita S Chester
Investigators
FDA investigators tied to this site in the record.
Edward Deberry4 insp.
Christopher S Keating2 insp.
Libia M Lugo1 insp.
Jared P Stevens1 insp.
Bonita S Chester1 insp.
Rachael L Cook1 insp.
Sonya M Edmonds1 insp.
Melanie M Walker1 insp.
Lillie D Witcher1 insp.
Anastasia M Shields1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.176 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind King Bio Inc's 7 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