Denver Solutions, LLC DBA Leiters Health – FDA 483, Jul 18, 2019

This FDA Form 483 document details observations from an inspection of a facility involved in drug compounding.

**Facility and Operations:** The inspection identified deficiencies in aseptic processing areas, specifically in Room 195 where (b)(4) occurs. The facility utilizes (b)(4)SO 5 laminar flow hoods for sterile compounding.

**Violations and Observations:** 1. **Deficient Aseptic Processing Areas:** On July 1, 2019, cracks and chips were observed on the acrylic view screens of (b)(4)SO 5 laminar flow hoods. Specifically, Hood (b)(4) had a 5-inch horizontal crack with a thick, uneven silicone caulk repair. This surface is not smooth or hard, potentially hindering disinfection and sanitization. 2. **Inadequate Cleaning Procedures:** The ISO 5 cleaning procedure (SOP 4.400 DEN) does not address cleaning the inside of the acrylic view screens and front surfaces within the ISO 5 laminar air flow space. On July 8, 2019, it was observed that these surfaces were not cleaned prior to compounding. 3. **Compounding of Copies of Approved Drugs:** The facility compounds drug products that are essentially copies of approved drugs, violating sections 503B(a)(5) and 503B(d)(2). This includes drugs identical or nearly identical to approved drugs not on