Hybrid Pharma LLC — FDA 483 Findings

Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required to perform their assigned functions.

Laboratory records do not include complete records of the periodic calibration of laboratory instruments.

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

Laboratory controls, do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.

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

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

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purpolied or represented to possess.

Your outsourcing facility compounds drug products using bulk drug 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 drug products that appear on the diug 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.