Winder Laboratories, Llc
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 828 Tucker Court Ste B, WINDER, Georgia (GA) 30680, United States (USA)
- Operations here
- manufacture
- FDA identifiers
- FEI 3008694072 · DUNS 116924103
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 1 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-08-05
- NAIBioresearch Monitoring2025-02-05
- VAIDrug Quality Assurance2020-03-13
- OAIDrug Quality Assurance2018-07-18
- NAIDrug Quality Assurance2017-06-09
- VAIDrug Quality Assurance2016-02-25
- VAIUnapproved and Misbranded Drugs2016-02-25
- VAIDrug Quality Assurance2015-12-03
- NAIDrug Quality Assurance2009-02-10
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- Diphenoxylate Hydrochloride and Atropine SulfateWinder Laboratories LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.