Bausch + Lomb Corporation
Overview
Bausch + Lomb Corporation is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world. The company offers a comprehensive portfolio of products, including contact lenses, lens care products, ophthalmic pharmaceuticals, vitreoretinal and surgical instruments and devices.
Core services & business areas
Therapeutic areas
FDA compliance signals
24 FDA enforcement records linked to this company.
- 4832025-02-27
Procedures for sterile drug products
- 4832025-02-27
Cleaning / Sanitizing / Maintenance
- 4832025-02-27
Sampling/testing of drug products
- 4832019-11-25
Procedures not in writing, fully followed
- 4832019-11-25
Buildings not maintained in good state of repair
- recall — Class III2019-06-19
Failed Stability Specifications: Out of specification for viscosity.
- 4832018-08-10
Procedures not in writing, fully followed
- 4832018-08-10
Deviations from laboratory control requirements
- 4832018-08-10
Extent of discrepancy, failure investigations
- 4832018-08-10
Second person sign off
- 4832018-08-10
Complete test data included in records
- recall — Class II2017-06-21
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
- 4832017-03-24
Instruments, apparatus, et. al. not meeting specs
- recall — Class III2016-02-03
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
- recall — Class III2016-02-03
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
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