Prescription and over-the-counter medications
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
cGMP deviations: due to shipment of rejected units.
SUN PHARMACEUTICAL INDUSTRIES
Presence of Foreign Substance: Metal embedded in a tablet.
Sagent Pharmaceuticals
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
New Vitalis Pharmacy LLC
Lack of Assurance of Sterility
Kramer Laboratories
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Defective Delivery System
Lack of Assurance of Sterility
New England Life Care, Inc.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
New England Life Care, Inc.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.