WINDER Laboratories, LLC
Form 483 issued August 5, 2025 · Winder, Georgia
- Inspection
- Jul 14 – Aug 5, 2025
- Investigators
- Samantha E. Cleek· Veronica Fuentes
- Observations
- 13
- Pages
- 17
- FEI number
- 3008694072
In short: On August 5, 2025, FDA issued a Form 483 with 13 observations to WINDER Laboratories, LLC in Winder, Georgia (FEI 3008694072) after an inspection that ran Jul 14 – Aug 5, 2025. The investigators were Samantha E. Cleek and Veronica Fuentes. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.166(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written procedures for sampling and testing plans are not followed…
- 03
Results of stability testing are not used…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Samantha E. Cleek
4 documents · 2024–2025
Cites 211.165(b) (testing and release for distribution) more than any other section. Most of their documents are for sites in Georgia.
The firmWINDER Laboratories, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WINDER Laboratories, LLC?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected WINDER Laboratories, LLC?
Samantha E. Cleek and Veronica Fuentes are named on this Form 483, for the inspection of Jul 14 – Aug 5, 2025. Each investigator has a profile showing what they cite most.
When was WINDER Laboratories, LLC inspected by FDA?
The inspection ran Jul 14 – Aug 5, 2025, and the Form 483 is dated August 5, 2025.
How do I get the full Form 483 for WINDER Laboratories, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.