SIMTRA US LLC
Overview
SIMTRA US LLC is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering 0.9% SODIUM CHLORIDE DILUENT, USP; STERILE WATER FOR INJECTION FOR RECONSTITUTION.
Core services & business areas
API / Drug Master Files
SIMTRA US LLC holds 2 active (2 total) FDA Type II Drug Master Files — 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.
- 0.9% SODIUM CHLORIDE DILUENT, USPActive2008-07-24
- STERILE WATER FOR INJECTION FOR RECONSTITUTIONActive2002-04-04
FDA compliance signals
7 FDA enforcement records linked to this company.
- 4832017-07-17
Validation lacking for sterile drug products
- 4832013-05-10
Certificates of Testing (Containers, Closures)
- 4832013-05-10
SOPs not followed / documented
- 4832013-05-10
Procedures not in writing, fully followed
- 4832013-05-10
Procedures To Be in Writing
- 4832013-03-12
Extent of discrepancy, failure investigations
- 4832013-03-12
Procedures for sterile drug products
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