US Specialty Formulations LLC – FDA 483, May 29, 2015

This FDA Form 483 details observations from an inspection, indicating significant deficiencies in a drug manufacturing facility, particularly concerning sterile drug production.

**Key Observations:**

* **Quality System Deficiencies:** * Investigations into unexplained discrepancies are not consistently documented. * Time limits for production phases are not established. * **Aseptic Processing & Environmental Control:** * Environmental monitoring systems in aseptic processing areas are deficient. * Cleaning and disinfection systems for aseptic areas and equipment are inadequate. * Protective apparel is not consistently worn to prevent drug product contamination. * **Sterilization & Contamination Control:** * Procedures to prevent microbiological contamination of sterile drug products are not established or adequately validated. * Sterilization processes lack adequate validation. * Each batch of sterile and pyrogen-free drug product is not laboratory tested for conformance. * **Facility & Equipment:** * Building location is unsuitable for cleaning, maintenance, and proper operations. * Equipment and utensils are not cleaned and maintained at appropriate intervals, risking contamination and malfunction. * **Product Release & Labeling:** * Drug products are not always tested for conformance to final specifications prior to release. * Drug product labels do not consistently contain information required by section 503B(a)(10)(A) and (B) of