Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-11.
At a glance
Inspections
11
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Oct 2024 – 11 Oct 2024 | Human Drugs | 483 | View 483 → |
| 2 Aug 2021 – 4 Aug 2021 | Human Drugs | 483 | View 483 → |
| 20 Dec 2017 – 27 Dec 2017 | Human Drugs | 483 | View 483 → |
| 24 Aug 2015 – 2 Sep 2015 | Human Drugs | 483 | View 483 → |
| 27 Jan 2014 – 7 Feb 2014 | Human Drugs | Clean | |
| 22 Sep 2010 | Not recorded | 483 | View 483 → |
| 22 May 2009 | Not recorded | 483 | On file |
| 1 Oct 2004 | Not recorded | Clean | |
| 3 Mar 2004 | Not recorded | Clean | |
| 24 Apr 2001 | Not recorded | Clean | |
| 18 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Oct 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Conner N Mann, Eric D Bowles
11 Oct 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Conner N Mann, Eric D Bowles
11 Oct 2024
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Conner N Mann, Eric D Bowles
Investigators
FDA investigators tied to this site in the record.
Conner N Mann1 insp.
Eric D Bowles1 insp.
Wayne D Mcgrath1 insp.
Veronica Fuentes1 insp.
Daniel R Hurt1 insp.
Michele L Obert1 insp.
Dewayne E Whitlock1 insp.
Lori Gioia1 insp.
Kellia N Hicks1 insp.
Judith Hillegas1 insp.
Patrick L Wisor1 insp.
Michael S Smoker1 insp.
Matthew R Sleeter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 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 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Custom Industrial Analysis Laboratories' 6 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