FDA 483 - Mihalko Medical, LLC - September 18, 2014

This FDA Form 483 document outlines several observations regarding a firm's manufacturing processes for sterile drug products. The primary issue identified is the lack of validation for sterilization processes.

Specifically, procedures designed to prevent microbiological contamination of sterile drug products do not include validation of the sterilization process. The firm has not validated the (b)(4) sterilization process by (b)(4) for injectable drug products, citing examples such as Histamine Phosphate (PF) 2.75mg/ml Sterile Inj lot 07072014@18 and Histamine (with preservative) 2.75mg/5ml Sterile Inj lot # 07292014@6.

Furthermore, the sterilization and depyrogenation processes for components like vials and stoppers, used in products such as Dexamethasone Sodium Phosphate (MDV) 16mg/ml Sterile Inj lot 06102014@7 and Mitomycin (0.02%) 0.2 mg/ml ophthalmic lot # 08112014@10, have not been validated. The (b)(4) sterilization for producing batches of injectable product has not been validated, and there is no documentation to qualify the (b)(4) used with regard to (b)(4).

The firm also lacks documentation to (b)(4) the (b)(4) or bioburden