Staska Pharmaceuticals Inc — FDA 483 Findings

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established or followed.

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

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

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

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

Bulk drug substances used by your outsourcing facility to compound drug products are not manufactured by an establishment that is registered under section 510 as required by section 503B(a)(2)(C).

Your firm failed to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.

The containers of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(B).