Chartwell Pharmaceuticals Congers, 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
- 77 Brenner Drive, Congers, New York (NY) 10920, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3008897678 · DUNS 118673447
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 35 drugs, 3 already in shortage. 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 Assurance2025-11-18
- VAIBioresearch Monitoring2024-04-08
- VAIDrug Quality Assurance2023-05-24
- VAIDrug Quality Assurance2018-09-26
- VAIBioresearch Monitoring2016-11-01
- NAIDrug Quality Assurance2014-06-23
- VAIDrug Quality Assurance2012-09-19
Drugs this plant is listed as making
35 distinct drugs across 72 products name this site in their FDA label.
- Albuterol SulfateChartwell RX, LLC.
- BudesonideChartwell RX, LLC
- Clindamycin HydrochlorideChartwell RX, LLC
- Cyproheptadine HydrochlorideChartwell RX, LLC
- Doxycycline MonohydrateChartwell RX, LLC.
- famotidineChartwell RX, LLC
- FluconazoleChartwell RX, LLC
- Folic AcidChartwell RX, LLC.
- griseofulvinHeritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc
- Griseofulvin (microsize)Chartwell RX, LLC.
- HydrocortisoneHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc
- Hyoscyamine sulfateChartwell RX, LLC
- Ketorolac Tromethaminein shortageChartwell RX, LLC
- LactuloseChartwell RX, LLC
- Meclizine HydrochlorideChartwell RX, LLC
- Methenamine MandelateChartwell RX, LLC
- Naltrexone HydrochlorideHeritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc
- OndansetronChartwell RX, LLC
- Pioglitazone HydrochlorideChartwell RX, LLC
- Posaconazole Delayed-ReleaseChartwell RX, LLC
- PrednisoloneChartwell RX, LLC
- Prochlorperazine MaleateChartwell RX, LLC
- Quinapril and Hydrochlorothiazidein shortageChartwell RX, LLC
- Rivastigmine TartrateChartwell RX, LLC
- Rosuvastain CalciumChartwell RX, LLC
- SildenafilChartwell RX, LLC
- Sodium Polystyrene SulfonateChartwell RX, LLC
- Sterile Waterin shortageChartwell RX, LLC
- Sulfamethoxazole and TrimethoprimChartwell RX, LLC
- TENOFOVIR DISOPROXIL FUMARATE TabletsChartwell RX, LLC.
- tetracycline hydrochlorideChartwell RX, LLC.
- Ultramicrosize GriseofulvinAyurax, LLC.
- Valproic AcidChartwell RX, 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.