Genentech, Inc.
Overview
Genentech, Inc., a biotechnology corporation, is a subsidiary of Roche Holding AG. The company specializes in developing and manufacturing products to treat patients with serious or life-threatening medical conditions, particularly in the areas of oncology, immunology, and neuroscience.
Therapeutic areas
API / Drug Master Files
Genentech, Inc. holds 1 active (7 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.
- MSBA30K PEG REAGENT FOR MIRCERA (RO0503819)Active2006-06-29
- CED88004AInactive2017-08-11
- CED88004SInactive2017-08-11
- DORNASE ALFA INHALATION SOLUTION (GENENTECH)Inactive1999-11-09
- THROMBOPOIETIN (HUMAN, RECOMBINANT, CHO CELLS, GENENTECH)Inactive1995-08-21
- TUMOR NECROSIS FACTOR RECEPTOR IMMUNOGLOBULIN GInactive1993-11-11
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SOUTH SAN FRANCISCO.Inactive1980-11-21
FDA compliance signals
28 FDA enforcement records linked to this company.
- recall — Class II2024-06-05
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- 4832024-05-02
Failure to comply with REMS Implementation System
- 4832024-04-19
Testing Calculations
- 4832024-04-19
Cleaning / Sanitizing / Maintenance
- 4832024-04-19
Scientifically sound laboratory controls
- 4832024-04-19
Written procedures not established/followed
- 4832024-04-19
Establishment of calibration procedures
- 4832024-04-19
Written record of investigation incomplete
- 4832024-04-19
Master production and control records, procedure
- recall — Class III2022-11-09
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
- recall — Class II2021-07-14
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
- recall — Class III2021-05-05
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
- 4832018-07-05
Establishment of calibration procedures
- 4832018-07-05
Following/documenting laboratory controls
- 4832018-07-05
Procedures for sterile drug products
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