Overview
- 22 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-08.
At a glance
Inspections
22
Form 483s
11
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Mar 2022 – 8 Apr 2022 | Human Drugs | 483 | View 483 → |
| 9 Apr 2018 – 16 May 2018 | Human Drugs | WL | On file |
| 20 Apr 2017 – 26 Apr 2017 | Human Drugs | 483 | View 483 → |
| 5 Dec 2016 – 9 Dec 2016 | Human Drugs | Clean | |
| 1 Jun 2016 – 10 Jun 2016 | Human Drugs | 483 | View 483 → |
| 28 May 2014 – 6 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Apr 2013 – 3 May 2013 | Human Drugs | 483 | View 483 → |
| 26 Oct 2012 | Not recorded | 483 | View 483 → |
| 25 May 2012 | Not recorded | 483 | View 483 → |
| 5 Aug 2011 | Not recorded | Clean | |
| 17 Sep 2010 | Not recorded | 483 | View 483 → |
| 30 Jun 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Ross J Grigsby, Michele L Glendenning, Jacob G Lutz, Eboni S Funderburk
8 Apr 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ross J Grigsby, Michele L Glendenning, Jacob G Lutz, Eboni S Funderburk
8 Apr 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Ross J Grigsby, Michele L Glendenning, Jacob G Lutz, Eboni S Funderburk
Investigators
FDA investigators tied to this site in the record.
Michele L Glendenning2 insp.
Brian D Nicholson2 insp.
Christopher D Leach2 insp.
Ross J Grigsby1 insp.
Jacob G Lutz1 insp.
Eboni S Funderburk1 insp.
Michele Perry-Williams1 insp.
Sandra A Hughes1 insp.
Samina S Khan1 insp.
Anastasia M Shields1 insp.
Patric C Klotzbuecher1 insp.
Rebecca Rodriguez1 insp.
Russell K Riley1 insp.
Joshua M Adams1 insp.
Nicholas P Diorio1 insp.
Kshitij A Patkar1 insp.
Denise M Digiulio1 insp.
Bruce H Mccullough1 insp.
Carl A Huffman1 insp.
Phung T Nguyen1 insp.
Debra I Love1 insp.
Lequita M Mayhew1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 11x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Akorn, 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