Chartwell Pharmaceuticals Carmel, 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
- 1033 Stoneleigh Ave, Carmel, New York (NY) 10512-2414, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3009686761 · DUNS 118673485
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-10-06
- VAIDrug Quality Assurance2019-12-16
- VAIDrug Quality Assurance2018-02-28
- VAIDrug Quality Assurance2015-11-02
- NAIBioresearch Monitoring2013-12-23
- VAIDrug Quality Assurance2013-12-23
- NAIDrug Quality Assurance2013-04-25
- VAIDrug Quality Assurance2013-03-25
- VAIDrug Quality Assurance2010-07-21
- NAIBioresearch Monitoring2009-04-22
- NAIDrug Quality Assurance2009-04-22
Drugs this plant is listed as making
13 distinct drugs across 17 products name this site in their FDA label.
- Cetirizine HydrochlorideAventura Pharmaceuticals, LLC
- Clonazepamin shortageChartwell RX, LLC
- Hydroxyzine HydrochlorideChartwell RX, LLC
- LevetiracetamChartwell RX, LLC
- Levocetirizine DihydrochlorideChartwell RX, LLC
- Lidocaine Hydrochloridein shortageChartwell RX, LLC
- Ondansetron HydrochlorideChartwell Governmental & Specialty RX, LLC.
- PhenobarbitalChartwell RX, LLC
- Potassium Citrate and Citric AcidChartwell RX, LLC
- prednisolone oral solutionHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
- RisperidoneChartwell 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.