Manufacturing facility
Direct Rx
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
- 94 World Wide Drive Suite 110, Dawsonville, Georgia (GA) 30534, United States (USA)
- Operations here
- relabelrepack
- FDA identifiers
- FEI 3011690045 · DUNS 079254320
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2026-06-04
- NAIDrug Quality Assurance2017-12-15
- VAIDrug Quality Assurance2015-08-13
Drugs this plant is listed as making
323 distinct drugs across 592 products name this site in their FDA label.
- Acetaminophen And CodeineDirect_Rx
- Acetaminophen and Codeine PhosphateDirect_Rx
- AcyclovirDirect_Rx
- AllopurinolDirect_Rx
- AlprazolamDirect_Rx
- Alprazolam C-IVDirect_Rx
- Alprazolam ODT C-IVDirect_Rx
- Amantadine HCLDirect_Rx
- Amitriptyline HCLDirect_Rx
- Amlodipine And Benazepril HydrochlorideDirect Rx
- Amlodipine BesylateDirect_Rx
- AmoxicillinDirect Rx
- Amoxicillin And Clavulanate PotassiumDirectRx
- Amoxicillin Oral SuspDirectRx
- Amoxicillin/Clav PotDirect_Rx
- Amoxicillin/Clav Pot Oral SuspDirect_Rx
- AnastrozoleDirect_Rx
- AripiprazoleDirect_Rx
- Armodafinildirect rx
- Atenololdirect rx
- Atorvastatin CalciumDirect Rx
- AzithromycinDirect_Rx
- Azithromycin DihydrateDirect Rx
- BaclofenDirect_Rx
- Benazepril HydrochlorideDirect Rx
- BenzonatateDirect Rx
- Benztropine MesylateDirect Rx
- Buprenorphine SublingualDirect_rx
- Buprenorphine Sublingual C-IIIDirect_Rx
- Bupropion HCLDirect_Rx
- Bupropion HCL ER (XL)Direct_RX
- Bupropion HCL ER(SR)DriectRx
- Bupropion HydrochlorideDirect Rx
- Bupropion Hydrochloride SrDirectRx
- Buspirone HCLDirect_Rx
- Buspirone HydrochlorideDirect Rx
- Butal/APAP/CaffDirect_Rx
- Butal/Apap/CaffeineDirect_Rx
- Carbamazepinedirect rx
- CarisoprodolDirect_Rx
- CarvedilolDirect_Rx
- CefadroxilDirect_Rx
- Cefazolin SodiumDirect_rx
- CefdinirDirect Rx
- CelecoxibDirectRx
- CephalexinDirect Rx
- ChlorthalidoneDirect_Rx
- Cilostazoldirect rx
- CiprofloxacinDirect_Rx
- ciprofloxacin hydrochlorideDirect Rx
- ClarithromycinDirectRx
- Clindamycin HydrochlorideDirect Rx
- Clobetasol PropionateDirect Rx
- Clonazepamin shortageDirect Rx
- Clonidine HydrochlorideDirectRX
- Clotrimazole And Betamethasone DipropionateDirect Rx
- Clotrimazole/BetamethDirect_Rx
- Colchicinedirect rx
- Cyclobenzaprine HCL ERDirect_Rx
- Cyclobenzaprine HydrochlorideDirect_Rx
- Desipramine HCLDirect_Rx
- Desvenlafaxine ErDirect_Rx
- desvenlafaxine succinateDirect Rx
- DexamethasoneDirect_Rx
- DiazepamDirect_Rx
- Diclofenac SodiumDirect_Rx
- Diclofenac Sodium D/RDirectRx
- Diclofenac Sodium GelDirect_Rx
- Diclofenac Sodium Topical SolutionDirect_Rx
- Diethylpropion Hydrochloride ErDirectrx
- Diltiazem HCL ERDirect_Rx
- diltiazem hydrochlorideDirectRx
- Diltiazem Hydrochloride Extended Releasedirect rx
- Diphenoxylate Hydrochloride And Atropine SulfateDirect Rx
- divalproex sodiumDirectRx
- Divalproex Sodium D/RDirect_Rx
- Divalproex Sodium ERDirect_Rx
- Donepezil HydrochlorideDirect_Rx
- Doxazosindirect rx
- Doxepin HCLDirect_rx
- Doxepin Hydrochloridedirect rx
- DoxycyclineDirect Rx
- Doxycycline HyclateDirect Rx
- Doxycycline MonohydrateDirect Rx
- Duloxetine D/RDirect_Rx
- Eletriptan HBRDirect_Rx
- Emtricitabine And Tenofovir Disoproxil FumarateDirectRx
- Emtricitabine/TDFDirect_Rx
- ErythromycinDirect Rx
- EscitalopramDirect_Rx
- Esomeprazole DRDirect_Rx
- Esomeprazole MagnesiumDirect Rx
- EstradiolDirect_Rx
- EszopicloneDirect Rx
- FamotidineDirect_Rx
- FinasterideDirect_Rx
- FluconazoleDirect Rx
- Fluoxetine HCLDirect_Rx
- Fluoxetine HydrochlorideDirect Rx
- Fluticasone PropionateDirect_RX
- Folic AcidDirect Rx
- Furosemidein shortageDirect Rx
- GabapentinDirect_Rx
- gentamicin sulfateDirect Rx
- Gentamicin Sulfate Opth SolutionDirect_Rx
- GlimepirideDirect_Rx
- Guanfacine ERDirect_Rx
- HydrochlorothiazideDirect Rx
- Hydrocodone APAPDirect_Rx
- Hydrocodone Bitartrate And AcetaminophenDirect Rx
- Hydrocodone/ApapDirect_Rx
- HydrocortisoneDirect Rx
- Hydrocortisone CreamDirect_Rx
- Hydroxyzine HCLDirect_rx
- Hydroxyzine HydrochlorideDirect Rx
- Hydroxyzine PamoateDirect_Rx
- Hyoscyamine Sulfate SublingualDirect_Rx
- IbuorofenDirect_Rx
- IbuprofenDirect Rx
- Ibuprofen FamotidineDirect_Rx
- ImiquimodDirect Rx
- IndapamideDirect_Rx
- IndomethacinDirect Rx
- Irbesartandirect rx
- Junel FEDirect_Rx
- KetoconazoleDirect Rx
- Ketoconazole CreamDirect_Rx
- Ketorolac Tromethaminein shortageDirect Rx
- LamotrigineDirect Rx
- Lamotrigine ERDirect_Rx
- Lansoprazole DRDirect_Rx
- LevetiracetamDirect Rx
- Levetiracetam ERDirect_Rx
- LevofloxacinDirect Rx
- levothyroxine liothyronineDirect Rx
- Levothyroxine SodiumDirect Rx
- levothyroxine, liothyronineDirect Rx
- LidocaineDirect_Rx
- Lidocaine PatchDirect_Rx
- Lidothol ES PatchDirect_Rx
- Lidothol GelDirect_Rx
- Lidothol PatchDirect_Rx
- Lisinopril/HCTZDirect_Rx
- Lorazepamin shortageDirect Rx
- Losartan PotassiumDirect Rx
- Losartan Potassium And HydrochlorothiazideDirect_Rx
- LubiprostoneDirect_Rx
- Lurasidone HCLDirect_rx
- Meclizine HydrochlorideDirect_Rx
- MeloxicamDirect Rx
- Memantine HCLDirect_Rx
- Memantine HydrochlorideDirectRx
- MetaxaloneDirect_Rx
- Metformin HCLDirect_Rx
- Metformin Hydrochloridedirect rx
- MethocarbamolDirect Rx
- MethylprednisoloneDirect_Rx
- Metoprolol SuccinateDirect_Rx
- Metoprolol Succinate ERDIrect_Rx
- Metoprolol TartrateDirect_Rx
- Metronidazolein shortageDirect_Rx
- MirtazapineDirect_Rx
- Montelukast SodiumDirect_Rx
- MoxifloxacinDirect Rx
- MupirocinDirect Rx
- Nabumetonedirect rx
- NaproxenDirect Rx
- Naproxen SodiumDirect Rx
- NebivololDirect_Rx
- Neo/Poly-B/Dex Ophth OintDirect_Rx
- neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ dropsDirectRx
- NitrofurantoinDirectrx
- Nitrofurantoin MacrocrystalsDirect_Rx
- Nitrofurantoin MonohydrateDirect_Rx
- Nitrofurantoin Monohydrate/MacrocrystalDirect_Rx
- Nortriptyline HCLDirect_rx
- Nortriptyline HydrochlorideDirect Rx
- NystatinDirect Rx
- OfloxacinDirect Rx
- Ofloxacin Ophth SolnDirect_Rx
- OlanzapineDirect_Rx
- Olfoxacin Otic SolnDirect_Rx
- Olmesartan Medoxomildirect rx
- Omeprazole/Sodiium BicarbonateDirect_rx
- OndansetronDirect Rx
- OxaprozinDirect_Rx
- OxcarbazepineDirectRx
- Oxybutynin Chloridedirect rx
- Oxycodone And AcetaminophenDirect_Rx
- Oxycodone HCLDirect_Rx
- Oxycodone HydrochlorideDirect Rx
- Oxycodone/APAPDirect_Rx
- pantoprazoleDirect Rx
- Pantoprazole Sodium DRDirect_Rx
- ParoxetineDirect Rx
- Phenazopyridine HCLDirect Rx
- Phentermine HCL C-IVDirect_Rx
- Phentermine HydrochlorideDirectRx
- Phenytoin SodiumDirect Rx
- PioglitazoneDirect Rx
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.