Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-05.
At a glance
Inspections
9
Form 483s
6
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2025 – 5 Aug 2025 | Human Drugs | WL | View 483 → |
| 4 Feb 2025 – 5 Feb 2025 | Human Drugs | Clean | |
| 24 Jan 2023 – 3 Feb 2023 | Human Drugs | 483 | View 483 → |
| 31 Jan 2022 – 11 Feb 2022 | Human Drugs | 483 | View 483 → |
| 9 Mar 2020 – 13 Mar 2020 | Human Drugs | 483 | View 483 → |
| 9 Jul 2018 – 18 Jul 2018 | Human Drugs | WL | On file |
| 5 Jun 2017 – 9 Jun 2017 | Human Drugs | Clean | |
| 25 Feb 2016 | Human Drugs | Clean | |
| 30 Nov 2015 – 3 Dec 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Aug 2025
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Veronica Fuentes, Samantha E Cleek
5 Aug 2025
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Veronica Fuentes, Samantha E Cleek
5 Aug 2025
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Veronica Fuentes, Samantha E Cleek
5 Aug 2025
21 CFR 211.165(c)
Sampling and testing plans not followed
Cited by Veronica Fuentes, Samantha E Cleek
Investigators
FDA investigators tied to this site in the record.
Susan O Oladeji2 insp.
Jawaid Hamid2 insp.
Veronica Fuentes1 insp.
Samantha E Cleek1 insp.
Brandy D Brown1 insp.
Ileana Barreto-Pettit1 insp.
Song Y Lavalais1 insp.
Pratik S Upadhyay1 insp.
Johnetta F Walters1 insp.
Kara D Dobbin1 insp.
Jason K Morgan1 insp.
Lillie D Witcher1 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 | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Winder Laboratories, LLC's 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