Denison Pharmaceuticals

39 FDA enforcement records linked to this company.

• recall — Class II2025-03-19

  Chemical Contamination: Presence of benzene.

• recall — Class III2024-11-13

  Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

• recall — Class III2024-11-13

  Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

• 4832024-07-29

  Procedures not in writing, fully followed

• 4832024-07-29

  Component addition checked by 2nd person

• 4832024-07-29

  Strict control not exercised over labeling issued

• 4832024-07-29

  Label storage access limited to authorized personnel

• 4832024-07-29

  Written records kept in individual logs

• 4832024-07-29

  Quality control unit review of records

• 4832024-07-29

  Cleaning / Sanitizing / Maintenance

• 4832024-07-29

  Sanitation--buildings not clean, free of infestation

• 4832024-07-29

  Buildings of Suitable Size, Construction, Location

• 4832024-07-29

  Absence of Written Procedures

• 4832024-07-29

  Investigations of discrepancies, failures

• recall — Class II2024-06-26

  cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.