Lack of Assurance of Sterility.
Edge Pharma
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Labeling: Incorrect or Missing Lot and/or Exp Date
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Labeling: Label Error on Declared Strength