Padagis US LLC

17 FDA enforcement records linked to this company.

• recall — Class II2026-07-22

  Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

• 4832026-04-08

  Scientifically sound laboratory controls

• 4832026-04-08

  Stability sample storage conditions described

• 4832026-04-08

  Written sanitation procedures not followed

• 4832026-04-08

  Absence of Written Procedures

• recall — Class II2025-03-05

  Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

• recall — Class III2024-11-27

  Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

• 4832024-09-06

  Cleaning SOP/inspection

• recall — Class II2023-12-13

  Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

• recall — Class II2023-11-08

  Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

• recall — Class III2023-03-22

  Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

• recall — Class II2022-09-07

  CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

• 4832022-02-18

  Procedures To Be in Writing

• 4832022-02-18

  Authority lacking to review records, investigate errors

• 4832022-02-18

  Procedures not in writing, fully followed