Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-01-14.
At a glance
Inspections
7
Form 483s
3
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jan 2021 – 14 Jan 2021 | Human Drugs | Clean | |
| 17 Sep 2018 – 21 Sep 2018 | Animal Drugs & Feeds | Clean | |
| 26 Aug 2013 – 30 Aug 2013 | Human Drugs | 483 | On file |
| 19 Feb 2013 – 20 Feb 2013 | Human Drugs | Clean | |
| 4 Jun 2009 | Not recorded | 483 | On file |
| 12 Feb 2009 | Not recorded | 483 | View 483 → |
| 20 Sep 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Feb 2009
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Linda M Cherry, Matthew R Dionne, James D Bradley, Terri L Thomas
12 Feb 2009
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Linda M Cherry, Matthew R Dionne, James D Bradley, Terri L Thomas
12 Feb 2009
21 CFR 211.56(c)
Written procedures lacking for use of pesticides etc.
Cited by Linda M Cherry, Matthew R Dionne, James D Bradley, Terri L Thomas
12 Feb 2009
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Linda M Cherry, Matthew R Dionne, James D Bradley, Terri L Thomas
12 Feb 2009
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Linda M Cherry, Matthew R Dionne, James D Bradley, Terri L Thomas
Investigators
FDA investigators tied to this site in the record.
Linda M Cherry2 insp.
Theressa B Smith1 insp.
Andrea S Heise1 insp.
Laura L Staples1 insp.
Ana C Lazo1 insp.
Stefanie R Cook1 insp.
Kimberley A Hoefen1 insp.
Teena H Aiken1 insp.
Matthew R Dionne1 insp.
James D Bradley1 insp.
Terri L Thomas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aliri USA Inc.'s 3 Form 483s
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