Seatex

18 FDA enforcement records linked to this company.

• warning_letter2024-04-01

  FDA Warning Letter (drug product)

• recall — Class II2024-03-06

  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

• recall — Class II2024-03-06

  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

• recall — Class II2024-03-06

  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

• recall — Class II2024-03-06

  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

• recall — Class II2024-03-06

  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

• 4832023-10-20

  Scientifically sound laboratory controls

• 4832023-10-20

  Complete test data included in records

• 4832023-10-20

  Procedures not in writing, fully followed

• 4832023-10-20

  Written procedures not established/followed

• 4832023-10-20

  Control procedures to monitor and validate performance

• 4832023-10-20

  Expiration date lacking

• recall — Class II2023-05-10

  Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

• 4832013-12-20

  Training , Education , Experience overall

• 4832013-12-20

  Adequate number of batches on stability