Spartan Chemical Company

22 FDA enforcement records linked to this company.

• 4832025-11-21

  Investigations of discrepancies, failures

• 4832025-11-21

  Description of containers, labels, et. al.

• 4832025-11-21

  Scientifically sound laboratory controls

• 4832025-11-21

  Adverse Drug Experience

• 4832022-12-12

  Records not made readily available to FDA

• 4832022-12-12

  Computer control of master formula records

• 4832022-12-12

  Reports of Analysis (Components)

• 4832022-12-12

  Scientifically sound laboratory controls

• warning_letter2021-12-15

  FDA Warning Letter (drug product)

• recall — Class II2021-04-21

  CGMP Deviations

• recall — Class II2021-04-21

  CGMP Deviations

• recall — Class II2021-04-21

  CGMP Deviations

• recall — Class II2021-04-21

  CGMP Deviations

• recall — Class I2021-04-21

  Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans

• recall — Class II2021-04-21

  CGMP Deviations