Overview
- 15 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-22.
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 |
|---|---|---|---|
| 18 Aug 2025 – 22 Aug 2025 | Human Drugs | 483 | View 483 → |
| 12 Jun 2023 – 13 Jun 2023 | Foods & Cosmetics | Clean | |
| 9 Mar 2020 – 13 Mar 2020 | Human Drugs | 483 | View 483 → |
| 4 May 2017 | Human Drugs | Clean | |
| 27 Feb 2017 – 2 Mar 2017 | Human Drugs | Clean | |
| 29 Aug 2016 – 2 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 10 Mar 2014 – 14 Mar 2014 | Human Drugs | Clean | |
| 11 Jul 2013 – 12 Jul 2013 | Foods & Cosmetics | Clean | |
| 24 Feb 2012 | Not recorded | Clean | |
| 4 Sep 2009 | Not recorded | 483 | On file |
| 29 Jul 2009 | Not recorded | Clean | |
| 8 Feb 2008 | Not recorded | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Aug 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Michael Araneta, Thuy Tram L Nguyen, Jeffrey T Prosterman
22 Aug 2025
21 CFR 211.194(a)(4)
Complete Test Data
Cited by Michael Araneta, Thuy Tram L Nguyen, Jeffrey T Prosterman
22 Aug 2025
21 CFR 211.194(c)
Testing and standardization of standards et. al.
Cited by Michael Araneta, Thuy Tram L Nguyen, Jeffrey T Prosterman
Investigators
FDA investigators tied to this site in the record.
Brandon C Heitmeier3 insp.
Laura L Staples2 insp.
Wendy R Blame2 insp.
Michael Araneta1 insp.
Thuy Tram L Nguyen1 insp.
Jeffrey T Prosterman1 insp.
Shelton L Stribling1 insp.
Tracy J Washington1 insp.
Matthew R Mcnew1 insp.
Stephen G Mclane1 insp.
Stephanie A Cochran1 insp.
Claire M Minden1 insp.
Natasha N Mccants1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chattem Inc's 4 Form 483s
Source PDFs 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