Aveva Drug Delivery Systems

19 FDA enforcement records linked to this company.

• recall — Class III2026-06-03

  Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

• 4832023-09-01

  Washing and toilet facilities are deficient

• 4832023-09-01

  Label storage access limited to authorized personnel

• recall — Class III2023-03-22

  Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

• recall — Class III2023-03-22

  Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

• 4832018-04-27

  Investigations made into any unexplained discrepancy

• 4832018-04-27

  Items to cover on annual reviews

• 4832018-04-27

  Complaint Handling Procedure

• 4832018-04-27

  Computer control of master formula records

• 4832018-04-27

  Changes to Procedures Not Reviewed, Approved

• 4832018-04-27

  Control procedures to monitor and validate performance

• 4832014-04-11

  Computer control of master formula records

• 4832014-04-11

  Training , Education , Experience overall

• 4832014-04-11

  Procedure Deviations Recorded and Justified

• 4832014-04-11

  Written procedures not established/followed