Beacon Hill Medical Pharmacy, P.C. – FDA 483, Jul 19, 2013

This FDA Form 483 was issued to Wisam Alawieh, President/CEO of Beacon Hill Medical Pharmacy, P.C., located at 18161 W 13 Mile Rd, Suite A1, Southfield, MI 48076-1113. The firm is identified as a producer of drug products. The inspection occurred on multiple dates between July 1 and July 19, 2013.

The inspection revealed thirteen observations regarding the firm's operations and quality systems:

1. **Microbiological Contamination Prevention:** Procedures for preventing microbiological contamination of sterile drug products are not established, written, or followed. This includes inadequate validation of aseptic processing (e.g., media fills lacking worst-case conditions, representative container closure systems, or equipment used), absence of in situ air pattern analysis, and observed aseptic practice deficiencies (e.g., handling sterile materials with non-sterile gloves, disruption of unidirectional airflow, inadequate protection for vials exiting aseptic areas).

2. **Equipment Cleaning and Maintenance:** Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals. Specifically, HEPA filter integrity testing is insufficient (lacking upstream particle challenge), and cleaning agents for the aseptic area are prepared in an unclassified area, not labeled sterile, and not demonstrated to be sporicidal or adequately decontaminating. Cleaning frequency is also not specified.

3. **Production and