MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)
Overview
MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering BETAMETHASONE, USP.
Core services & business areas
API / Drug Master Files
MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) 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.
- BETAMETHASONE, USPActive1998-04-03
FDA compliance signals
11 FDA enforcement records linked to this company.
- 4832018-10-12
Cleaning/maintenance records not kept
- 4832018-10-12
Clothing appropriate for duties performed
- 4832017-03-16
Cleaning / Sanitizing / Maintenance
- 4832017-03-16
Written record of investigation incomplete
- 4832017-03-16
Equipment to control conditions
- 4832017-03-16
Environmental Monitoring System
- 4832015-03-17
Control procedures to monitor and validate performance
- 4832015-03-17
Lab controls established, including changes
- 4832015-03-17
Sanitation--buildings not clean, free of infestation
- 4832015-03-17
Procedures for sterile drug products
- 4832014-09-05
Procedures not in writing, fully followed
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