Prescription and over-the-counter medications
Golden State Medical Supply
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
Golden State Medical Supply
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
First Pharma Associates LLC
Lack of Assurance of Sterility.
Golden State Medical Supply
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
PharMEDium Services
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Defective Container; actuator may improperly function and affect dose delivery.
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.