FDA 483 - Vann Healthcare Services Inc - September 30, 2015

This FDA Form 483 was issued to Jennifer G. Wood, Pharmacist in Charge at Vann Healthcare Services Inc, a pharmacy compounder located at 1220 N Race St, Glasgow, KY 42141-3462. The inspection occurred from September 15 to September 30, 2015.

Four observations were noted:

1. **Deficient Control Systems:** The firm's control systems were inadequate to prevent contamination or mix-ups. Specifically, Dexamethasone 24 mg/ml injection solution (lot 05082015@1), a sterile product, was manufactured on May 8, 2015, under non-sterile conditions in a compounding area.

2. **Lack of Microbiological Contamination Prevention Procedures:** Procedures to prevent microbiological contamination of sterile drug products were not established. For Dexamethasone 24 mg/ml injection solution (lot 05082015@1), while the Logged Formula Worksheet indicated compounding in a laminar flow hood using aseptic technique and (b)(4), the Pharmacist in Charge stated the product was (b)(4) as part of the process, but the entire compounding process, including the (b)(4), was not conducted under sterile conditions.

3. **Inadequate Control of Rejected Components:** Rejected components were not controlled under a quarantine system to