Kvk-Tech, Inc.
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
- 110 TERRY DR., NEWTOWN, Pennsylvania (PA) 18940, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3005117563 · DUNS 173360061
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 29 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 Assurance2025-03-14
- NAIBioresearch Monitoring2024-10-21
- OAIDrug Quality Assurance2022-07-08
- OAIDrug Quality Assurance2019-04-16
- NAIBioresearch Monitoring2018-09-21
- VAIDrug Quality Assurance2017-06-27
- NAIBioresearch Monitoring2014-12-11
- VAIDrug Quality Assurance2014-12-11
- VAIDrug Quality Assurance2013-12-09
- VAIBioresearch Monitoring2012-09-17
- VAIDrug Quality Assurance2011-08-01
- VAIDrug Quality Assurance2009-12-16
- VAIDrug Quality Assurance2009-08-31
Drugs this plant is listed as making
29 distinct drugs across 69 products name this site in their FDA label.
- Benzhydrocodone and AcetaminophenZevra Therapeutics, Inc.
- betaxolol hydrochlorideKvk-Tech, Inc.
- Butalbital, Acetaminophen and CaffeineKVK-Tech, Inc.
- Cyclobenzaprine HydrochlorideKVK-TECH, Inc.
- Desmopressin Acetatein shortageKvk-Tech, Inc.
- Dexmethylphenidate HydrochlorideKvk-Tech, Inc
- Dextroamphetamine SulfateKVK-Tech, Inc.
- Diethylpropion HydrochlorideKvk-Tech, Inc
- Hydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.
- Hydrocodone Bitartrate and Homatropine MethylbromideKVK-Tech, Inc.
- hydrocodone bitartrate and homatropine methylbromide oral solutionKVK-Tech, Inc.
- hydroxyzine hydrochlorideKVK-Tech, Inc.
- IndomethacinKVK-Tech, Inc.
- LeflunomideKVK-Tech, Inc.
- Methylphenidate Hydrochloridein shortageKvk-Tech, Inc.
- methylphenidate hydrochloride extended releaseKVK-Tech, Inc.
- Oxybutynin ChlorideKVK-Tech, Inc.
- Oxycodone and AcetaminophenKVK-Tech, Inc.
- Oxycodone HydrochlorideKvk-Tech,inc
- Oxymorphone HydrochlorideKVK-Tech, Inc.
- Phendimetrazine TartrateKvk-Tech, Inc
- Phentermine HydrochlorideKvk-Tech, Inc.
- promethazine hydrochloridein shortageKVK-Tech, Inc.
- Sodium Polystyrene SulfonateKVK-Tech, Inc.
- UrsosiolKVK-Tech, Inc.
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.