Overview
- 15 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-19.
At a glance
Inspections
15
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Sep 2023 – 19 Oct 2023 | Human Drugs | 483 | View 483 → |
| 23 Jul 2018 – 27 Jul 2018 | Human Drugs | Clean | |
| 30 Apr 2018 – 4 May 2018 | Human Drugs | Clean | |
| 14 Aug 2017 | Human Drugs | Clean | |
| 13 Apr 2015 – 17 Apr 2015 | Human Drugs | Clean | |
| 12 Aug 2014 – 15 Aug 2014 | Human Drugs | Clean | |
| 15 Apr 2014 – 23 Apr 2014 | Human Drugs | Clean | |
| 19 Sep 2013 – 23 Sep 2013 | Human Drugs | Clean | |
| 19 Jun 2013 – 28 Jun 2013 | Human Drugs | 483 | View 483 → |
| 29 Jun 2012 | Not recorded | Clean | |
| 4 Nov 2011 | Not recorded | 483 | On file |
| 23 Nov 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Oct 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.198(a)
Complaints reviewed by Quality Control Unit
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Ucheabuchi C Chudi-Nwankwor
Investigators
FDA investigators tied to this site in the record.
Michael P Sheehan7 insp.
Ucheabuchi C Chudi-Nwankwor4 insp.
Lindsey M Schwierjohann1 insp.
Ruo H Xu1 insp.
Hang N Guo1 insp.
Cynthia T Cain1 insp.
Nicholas L Paulin1 insp.
Tracey L Harris1 insp.
Dell S Moller1 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 | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alkermes, Inc's 4 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