American Regent, Inc.

36 FDA enforcement records linked to this company.

• recall — Class III2026-05-06

  Labeling: Missing Label

• 4832026-03-05

  Investigations of discrepancies, failures

• 4832026-03-05

  Procedures not in writing, fully followed

• 4832026-01-29

  Investigations of discrepancies, failures

• 4832026-01-29

  Rejecting When Specifications Not Met

• 4832026-01-29

  Procedures for sterile drug products

• 4832026-01-29

  Procedures not in writing, fully followed

• recall — Class II2025-05-07

  Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

• recall — Class II2025-05-07

  Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

• recall — Class II2024-12-11

  Presence of Particulate Matter: Potential for glass delamination from the vials.

• recall — Class II2024-12-11

  Presence of Particulate Matter: Potential for glass delamination from the vials.

• recall — Class II2024-12-11

  Presence of Particulate Matter: Potential for glass delamination from the vials.

• recall — Class II2024-05-29

  Lack of Assurance of Sterility.

• recall — Class II2024-05-29

  Subpotent product in addition to having out-of-specification results for impurities.

• 4832024-04-24

  Computer control of master formula records