Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-29.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 29 Jul 2025 | Human Drugs | WL | View 483 → |
| 14 Nov 2023 – 22 Nov 2023 | Human Drugs | 483 | View 483 → |
| 16 Sep 2021 – 30 Sep 2021 | Human Drugs | 483 | View 483 → |
| 4 Jun 2019 – 19 Jun 2019 | Human Drugs | 483 | On file |
| 24 Oct 2017 – 9 Nov 2017 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jul 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Nicholas L Hunt, Stephon D Tillis, Michael Z Weigman
29 Jul 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Nicholas L Hunt, Stephon D Tillis, Michael Z Weigman
29 Jul 2025
21 CFR 211.166(a)
Lack of written stability program
Cited by Nicholas L Hunt, Stephon D Tillis, Michael Z Weigman
29 Jul 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Nicholas L Hunt, Stephon D Tillis, Michael Z Weigman
29 Jul 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicholas L Hunt, Stephon D Tillis, Michael Z Weigman
Investigators
FDA investigators tied to this site in the record.
Nicholas L Hunt3 insp.
Stephon D Tillis1 insp.
Michael Z Weigman1 insp.
Bryan L Mcguckin1 insp.
Christopher M Jenner1 insp.
Alan M Barker1 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 | 5x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(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 Signature Formulations, LLC's 5 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