Chemical Contamination: Presence of benzene.
Denison Pharmaceuticals
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class I - Dangerous
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class I - Dangerous
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class I - Dangerous
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.