Hybrid Pharma LLC — FDA 483 Findings

Testing and release ofdmg product for distribution do not include appropriate laborato1y dete1mination of satisfact01y conf01mance to the final specifications and identity and strength of each active ingredient prior to release.

Yom outsomcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) ofthe Federal Food, Drng, and Cosmetic Act (FD&C Act).

Aseptic processing areas are deficient in that floors, walls and ceilings ai·e not smooth and/or hard surfaces that are easily cleanable.

Procedures designed to prevent microbiological contamination of drng products purpo1iing to be sterile did not include adequate validation of the aseptic process.

Master production and control records lack complete manufacturing and control instrnctions, sampling and testing procedures, specifications, special notations and precautions to be followed.

Equipment used in the manufacture, processing, packing or holding of drng products is not of appropriate design to facilitate operations for its cleaning and maintenance.

Your outsourcing facility compounds dmg products using bulk drng substances that cannot be used in compounding under section 503B of the Federal Food, Drng, and Cosmetic Act (FD&C Act) because they (a) are not used to compound drng products that appear on the drug shmtage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drng substances for which there is a clinical need.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency pru.1iculate air filters under positive pressure.

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.

Laboratmy controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, chug product containers, closures, in-process materials, labeling and chug products conform to appropriate standards ofidentity, strength, quality and purity.