Overview

LIEBEL-FLARSHEIM CO LLC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering IOVERSOL, DRUG SUBSTANCE FOR OPTIRAY.

Core services & business areas

Pharmaceutical Manufacturing

API / Drug Master Files

LIEBEL-FLARSHEIM CO LLC holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

  • IOVERSOL, DRUG SUBSTANCE FOR OPTIRAYActive1996-12-06

FDA compliance signals

6 FDA enforcement records linked to this company.

  • warning_letter2025-10-17

    FDA Warning Letter (drug product)

  • 4832025-04-08

    Scientifically sound laboratory controls

  • 4832025-04-08

    Buildings not maintained in good state of repair

  • 4832025-04-08

    Written record of investigation incomplete

  • 4832025-04-08

    Training , Education , Experience overall

  • 4832025-04-08

    Floors, walls, ceiling surfaces

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