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
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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