Overview
- 25 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-18.
At a glance
Inspections
25
Form 483s
9
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2026 – 18 Feb 2026 | Human Drugs | 483 | On file |
| 14 Aug 2023 – 24 Aug 2023 | Human Drugs | 483 | View 483 → |
| 18 May 2022 – 30 Jun 2022 | Human Drugs | 483 | On file |
| 30 Apr 2020 – 18 May 2020 | Human Drugs | 483 | View 483 → |
| 29 Nov 2018 – 3 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 17 Sep 2015 – 18 Sep 2015 | Human Drugs | Clean | |
| 17 Aug 2015 – 1 Sep 2015 | Human Drugs | 483 | View 483 → |
| 25 Sep 2013 – 11 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jan 2013 | Not recorded | Clean | |
| 20 Dec 2011 | Not recorded | Clean | |
| 18 Mar 2011 | Not recorded | Clean | |
| 12 Feb 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Andrew J Barrowcliff, Chad W Rice, Nicholas J Presto, Alan M Barker
18 May 2020
21 CFR 211.111
Establishment of time limitations
Cited by Brian D Nicholson, Michele L Glendenning
18 May 2020
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Brian D Nicholson, Michele L Glendenning
18 May 2020
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Brian D Nicholson, Michele L Glendenning
18 May 2020
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Brian D Nicholson, Michele L Glendenning
Investigators
FDA investigators tied to this site in the record.
Brian D Nicholson4 insp.
Christopher D Leach4 insp.
Bruce H Mccullough3 insp.
Andrew J Barrowcliff2 insp.
Russell K Riley2 insp.
Phung T Nguyen2 insp.
Robert J Ham1 insp.
Joohi Castelvetere1 insp.
Angela C Welker1 insp.
JeanClaude Garay1 insp.
Chad W Rice1 insp.
Nicholas J Presto1 insp.
Alan M Barker1 insp.
Nicholas P Diorio1 insp.
Nibin Varghese1 insp.
Joseph A Piechocki1 insp.
Michele L Glendenning1 insp.
Shafiq Ahadi1 insp.
John M Seale1 insp.
Joseph A Morkunas1 insp.
Janae D Price1 insp.
Carrie-Ann Plucinski1 insp.
Susan P Bruederle1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.132(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.176 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(g)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(g)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.132(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.132(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | 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(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(6) | 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(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | 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 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fresenius Kabi USA LLC's 9 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