FDA 483 - Health Dimensions, Inc. - August 08, 2014

This FDA Form 483 was issued to Health Dimensions, Inc., a producer of sterile drug products located at 39303 Country Club Dr., Suite A26, Farmington Hills, MI 48331-3482. The inspection occurred from July 31, 2014, to August 8, 2014. Mr. Scott T. Popyk, R.Ph, President, was the recipient of the report.

The inspection revealed five observations:

1. **Procedures to prevent microbiological contamination are not written and followed.** * **Aseptic Process Simulations (Media Fills):** Inadequate media fills were performed, not reflecting worst-case conditions or actual production processes (e.g., sterile filtering into open, unstoppered vials, use of vent needles/nitrogen gas). * **Environmental Monitoring (EM) Program:** Inadequate, with active viable, non-viable particulate, and viable surface EM not performed during every drug production shift in critical areas (only weekly samples collected). * **Materials Sanitization and Transfer:** Inadequate, with no sanitization step when materials transfer from ISO 7 buffer room to ISO 5 workbenches. Airflow in the ISO 7 buffer room was observed to eddy. * **Gowning:** Inadequate, with sterile garb not covering all exposed areas (e.g.,