Steriscience Sp Z O O
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
- Poland
- Registered address
- Ul Daniszewska 10, Warszawa, Mazowieckie 03-230, Poland (POL)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3009685660 · DUNS 522218056
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-02-09
- VAIDrug Quality Assurance2023-04-28
- OAIDrug Quality Assurance2014-02-14
- VAIDrug Quality Assurance2012-09-13
Drugs this plant is listed as making
8 distinct drugs across 13 products name this site in their FDA label.
- DoxycyclineSteriscience Specialties Private Limited
- Fosaprepitant DimeglumineSteriscience Specialties Private Limited
- Methylene blueAmneal Pharmaceuticals LLC
- Rocuronium Bromidein shortageSteriscience Specialties Private Limited
- Sodium Bicarbonatein shortageSteriscience Specialties Private Limited
- Vancomycin HydrochlorideSteriscience Specialties Private Limited
- ziprasidone mesylateSteriscience Specialties Private Limited
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.