CGMP Deviations
Medisca
CGMP Deviations and Presence of Particulate Matter: Glass
Failed Impurities/Degradation Specifications
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.