Par Health USA, 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
- 870 Parkdale Road, Rochester, Michigan (MI) 48307, United States (USA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 1818977 · DUNS 119548429
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 Assurance2025-10-20
- VAIDrug Quality Assurance2023-04-14
- VAIBlood and Blood Products2021-10-22
- VAIVaccines and Allergenic Products2021-10-22
- VAIDrug Quality Assurance2019-04-15
- VAIBlood and Blood Products2018-08-09
- VAIVaccines and Allergenic Products2018-08-09
- VAIDrug Quality Assurance2017-03-13
- NAIDrug Quality Assurance2015-09-28
- VAIDrug Quality Assurance2015-09-10
- VAIDrug Quality Assurance2014-02-10
- VAIDrug Quality Assurance2012-12-28
- VAIDrug Quality Assurance2012-03-29
- VAIBlood and Blood Products2011-08-05
- VAIDrug Quality Assurance2011-06-08
- VAIDrug Quality Assurance2010-08-31
- VAIDrug Quality Assurance2010-02-18
- VAIBlood and Blood Products2009-09-22
- VAIDrug Quality Assurance2009-07-17
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- epinephrinePar Health USA, 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.