Sanofi-Aventis U.S. LLC
Overview
Sanofi-Aventis U.S. LLC is the U.S. subsidiary of Sanofi, a multinational pharmaceutical company headquartered in Paris, France. The company is engaged in the research, development, manufacturing, and marketing of healthcare products, with a strong emphasis on innovative solutions in various therapeutic areas.
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Sanofi-Aventis U.S. LLC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
FDA compliance signals
22 FDA enforcement records linked to this company.
- recall — Class II2023-05-24
Lack of Assurance of Sterility: Malformed crimped collar seal
- recall — Class II2020-08-26
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-12-11
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2018-07-18
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
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