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.

Therapeutic areas

OphthalmologyVision CareSurgical

FDA compliance signals

24 FDA enforcement records linked to this company.

  • 4832025-02-27

    Sampling/testing of drug products

  • 4832025-02-27

    Cleaning / Sanitizing / Maintenance

  • 4832025-02-27

    Procedures for sterile 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

    Second person sign off

  • 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

    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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