Apollo Care LLC — FDA 483 Findings

(Repeat) There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

(Repeat) Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas.

Each component is not tested for confonnity with all appropriate written specifications for purity, strength, and quality.

(Repeat) Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 5038 because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

(Repeat) Buildings used in the manufacture, processing, packing, or holding of a drug do not have the suitable construction and location to facilitate cleaning, maintenance, and proper operations.

There is a failure of the quality control unit to secure their responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling.