Overview
- 12 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-31.
At a glance
Inspections
12
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2024 – 31 Jan 2024 | Biologics | 483 | View 483 → |
| 5 Nov 2018 – 12 Nov 2018 | Biologics | 483 | View 483 → |
| 7 Jun 2017 – 14 Jun 2017 | Biologics | 483 | On file |
| 8 Jul 2015 – 13 Jul 2015 | Biologics | 483 | On file |
| 6 Aug 2013 – 12 Aug 2013 | Biologics | 483 | On file |
| 27 Sep 2011 | Not recorded | 483 | On file |
| 13 Nov 2009 | Not recorded | 483 | On file |
| 18 Apr 2008 | Not recorded | 483 | On file |
| 27 Jun 2006 | Not recorded | Clean | |
| 16 Mar 2004 | Not recorded | Clean | |
| 23 May 2002 | Not recorded | Clean | |
| 15 Dec 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Gene D Arcy, Priscilla M Pastrana
31 Jan 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Gene D Arcy, Priscilla M Pastrana
31 Jan 2024
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Gene D Arcy, Priscilla M Pastrana
Investigators
FDA investigators tied to this site in the record.
Prabhu P Raju3 insp.
Gene D Arcy1 insp.
Priscilla M Pastrana1 insp.
Arie Menachem1 insp.
Colleen F Hoyt1 insp.
Simone E Pitts1 insp.
Omotunde O Osunsanmi1 insp.
Joey V Quitania1 insp.
Nicole K Trudel1 insp.
Paula A Trost1 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 | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | 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 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Allermed Laboratories, 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