# FDA 483 - Denver Solutions, LLC DBA Leiters Health - July 18, 2019

Source: https://www.keypedia.com/records/483/denver-solutions-llc-dba-leiters-health/9e0a7db3-80b2-462c-8f99-9ac9930232fc

> FDA 483 for Denver Solutions, LLC DBA Leiters Health on July 18, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Denver Solutions, LLC DBA Leiters Health
- Inspection Date: 2019-07-18
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: 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

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## Related Officers

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Company: https://www.keypedia.com/companies/denver-solutions-llc-dba-leiters-health/bda60157-b3a1-41a3-bb4f-7e3adecdd6e3

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face