WINDER Laboratories, LLC
FDA inspection history across 2 sites, 2018 to 2026
- 4
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter; 2020: one Form 483; 2023: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–20Two Form 483s and one close-out letter, at WINDER, Georgia and Winder, Georgia.
- 2023–26Two Form 483s and one warning letter, at WINDER, Georgia and Winder, Georgia.
- 2025The longest 483 on file: 13 observations over 17 pages at Winder, Georgia.
Cited most
Across all WINDER Laboratories observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.142Warehousing procedures3
- 21 CFR 211.160General requirements3
- 21 CFR 211.166Stability testing3
The complete WINDER Laboratories file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Winder, Georgia
One warning letter, one Form 483 and one close-out letter · 2019 to 2026 · 13 observations
Latest: Warning letter, Jan 7, 2026 →WINDER, Georgia
Three Form 483s · 2018 to 2023 · 21 observations
Latest: Form 483, Feb 3, 2023 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-07 | Warning letter Warning letter | Winder, Georgia | — | $99 |
| 2025-08-05 | 483 Form 483 | Winder, Georgia | 13 | $99 |
| 2023-02-03 | 483 Form 483 | WINDER, Georgia | 4 | $99 |
| 2020-03-13 | 483 Form 483 | WINDER, Georgia | 4 | $99 |
| 2019-03-26 | Close-out Close-out letter | Winder, Georgia | — | $99 |
| 2018-07-18 | 483 Form 483 | WINDER, Georgia | 13 | $99 |
Investigators on these documents
Susan O. Oladeji (2)Johnetta F. Walters (1)Pratik S. Upadhyay (1)Samantha E. Cleek (1)Veronica Fuentes (1)
FEI number 3008694072 · most recent document Jan 7, 2026
About WINDER Laboratories, LLC
How many FDA Form 483s has WINDER Laboratories, LLC received?
FDA Intel has 4 Form 483s on file for WINDER Laboratories, LLC; the most recent is dated Aug 5, 2025.
When was WINDER Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for WINDER Laboratories, LLC is a Form 483 dated Aug 5, 2025, for the site in Winder, Georgia.
What did FDA cite at WINDER Laboratories, LLC?
The regulations cited most in the observations on file for WINDER Laboratories, LLC are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.142 (Warehousing procedures), 3 times.
Has WINDER Laboratories, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for WINDER Laboratories, LLC; the most recent is dated Jan 7, 2026.