Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
At a glance
Inspections
10
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2025 – 13 Jun 2025 | Human Drugs | 483 | View 483 → |
| 4 Oct 2022 – 21 Oct 2022 | Human Drugs | 483 | View 483 → |
| 19 Apr 2021 – 3 May 2021 | Human Drugs | 483 | View 483 → |
| 31 Jan 2019 – 1 Mar 2019 | Human Drugs | WL | View 483 → |
| 26 Nov 2018 – 29 Nov 2018 | Human Drugs | Clean | |
| 9 Aug 2017 – 19 Sep 2017 | Human Drugs | 483 | View 483 → |
| 18 Aug 2014 – 26 Aug 2014 | Human Drugs | 483 | On file |
| 19 Dec 2012 | Not recorded | 483 | On file |
| 18 May 2012 | Not recorded | 483 | On file |
| 6 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Sandra A Boyd, Anthony J Donato, Robin P Mathew
13 Jun 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Sandra A Boyd, Anthony J Donato, Robin P Mathew
13 Jun 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Sandra A Boyd, Anthony J Donato, Robin P Mathew
13 Jun 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Sandra A Boyd, Anthony J Donato, Robin P Mathew
13 Jun 2025
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Sandra A Boyd, Anthony J Donato, Robin P Mathew
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak2 insp.
Sandra A Boyd1 insp.
Anthony J Donato1 insp.
Robin P Mathew1 insp.
Lori M Newman1 insp.
Sean R Marcsisin1 insp.
Erik W Koester1 insp.
Jonah S Ufferfilge1 insp.
Kent A Conforti1 insp.
Jose O Hernandez1 insp.
Nealie C Newberger1 insp.
Jose A Cruz Gonzalez1 insp.
Charles Cote1 insp.
Robert J Martin1 insp.
Allison A Aldridge1 insp.
Ramon E Martinez1 insp.
Mark R Mcclain1 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 | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | 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)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.48(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ALK-Abello, Inc.'s 8 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