Prescription Drugs

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Subpotent Drug: Low assay result observed during long-term stability testing.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

CGMP Deviations: potential for trace amounts of product carryover.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

CGMP Deviations:

CGMP Deviations:

CGMP Deviations:

Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

CGMP Deviations: