Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-05.
At a glance
Inspections
9
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 May 2023 – 5 Jun 2023 | Human Drugs | 483 | View 483 → |
| 17 Jan 2019 – 25 Jan 2019 | Human Drugs | 483 | View 483 → |
| 13 Feb 2018 – 16 Feb 2018 | Human Drugs | 483 | View 483 → |
| 16 Jun 2014 – 18 Jun 2014 | Human Drugs | Clean | |
| 1 Mar 2012 | Not recorded | Clean | |
| 28 Jan 2010 | Not recorded | 483 | View 483 → |
| 19 Jul 2007 | Not recorded | Clean | |
| 17 Mar 2005 | Not recorded | Clean | |
| 29 May 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jan 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Carrie A Hughes, Bryan A Galvez
25 Jan 2019
21 CFR 211.194(a)
Complete test data included in records
Cited by Carrie A Hughes, Bryan A Galvez
25 Jan 2019
21 CFR 211.68(b)
Written record not kept of program and validation data
Cited by Carrie A Hughes, Bryan A Galvez
Investigators
FDA investigators tied to this site in the record.
Caryn M Mcnab2 insp.
Youkeun Kim1 insp.
Tiara M Brown1 insp.
Carrie A Hughes1 insp.
Bryan A Galvez1 insp.
Rumany C Penn1 insp.
Teresa T Cain1 insp.
Virgilio F Pacio1 insp.
Tracey T Duong1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ALS Group USA, Corp.'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