Carie Boyd Pharmaceuticals LLC – FDA 483, Nov 12, 2019

This FDA Form 483, issued to Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop, an outsourcing facility in Irving, TX, following an inspection from October 28 to November 12, 2019, details nine observations.

**Facility and Operations:** The firm is an outsourcing facility.

**Violations and Observations:**

1. **Aseptic Processing Area Deficiencies (Equipment Control):** Room certifications (June 22, 2019) were inadequate as they were conducted at rest, not under dynamic conditions, despite approximately [(b)(4)] batches of sterile injectable drug products being filled since then. No smoke studies were conducted for ISO5 LAFHs under dynamic conditions, where approximately [(b)(4)] batches of sterile injectable drug products were filled. The firm failed to properly review ISO7 anteroom positive pressure from August 19 to October 17, 2019, leading to an unawareness of consistent pressure loss until October 17, 2019. 2. **Aseptic Processing Area Deficiencies (Cleaning/Disinfection):** The firm does not follow or record contact times for disinfectants. An observation on October 28, 2019, showed a sterile technician immediately wiping dry an ISO5 LAFH after applying [(b)(4)], despite the disinfectant efficacy study stating a [(b)(4)] contact