Overview
- 14 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-18.
At a glance
Inspections
14
Form 483s
10
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2025 – 18 Feb 2025 | Human Drugs | 483 | View 483 → |
| 15 Oct 2019 – 21 Oct 2019 | Human Drugs | 483 | View 483 → |
| 1 Mar 2018 – 14 Mar 2018 | Human Drugs | Clean | |
| 14 Nov 2016 – 21 Nov 2016 | Human Drugs | 483 | View 483 → |
| 11 May 2015 – 15 May 2015 | Human Drugs | 483 | View 483 → |
| 14 Aug 2014 – 26 Aug 2014 | Human Drugs | 483 | View 483 → |
| 13 Dec 2012 | Not recorded | 483 | View 483 → |
| 15 Jun 2012 | Not recorded | 483 | View 483 → |
| 16 Mar 2011 | Not recorded | 483 | View 483 → |
| 19 Jan 2010 | Not recorded | 483 | View 483 → |
| 25 Nov 2008 | Not recorded | 483 | View 483 → |
| 21 May 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Feb 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz
18 Feb 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz
18 Feb 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz
18 Feb 2025
21 CFR 211.22(a)
Approve or reject components, products
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz
21 Oct 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey D Meng, Alan M Roberts, Jacob G Lutz
Investigators
FDA investigators tied to this site in the record.
Rebecca E Dombrowski5 insp.
Emily J Orban3 insp.
Jacob G Lutz2 insp.
Jeffrey D Meng2 insp.
Emilie Kahn2 insp.
Sarah M Napier2 insp.
Joohi Castelvetere1 insp.
Nicholas J Presto1 insp.
Alan M Roberts1 insp.
Bei Y He1 insp.
Aurora-Miha Trifanov1 insp.
Michele L Forster1 insp.
Sanket N Patel1 insp.
Thomas J Arista1 insp.
Caroline H Le1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | 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 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind King Pharmaceuticals LLC's 10 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