FDA 483 - Total Pharmacy Services, Inc. - September 30, 2014

An FDA inspection of Total Pharmacy Services, Inc., a producer of sterile products located at 7906 Park Ave, Houma, LA 70364, was conducted from September 23 to September 30, 2014. Peter H. Wolfe, Jr. is the owner.

The inspection revealed six observations:

1. **Sterilization Process Validation:** Procedures to prevent microbiological contamination of sterile drug products lack validation of the sterilization process. Specifically, the firm has not qualified its sterilization method for non-sterile drug components, sterilization equipment is not qualified under dynamic/operational conditions, and media fills have not been performed since January 2014, only including 10 ml vials.

2. **Environmental Monitoring:** Aseptic processing areas have deficient environmental monitoring systems. The firm does not perform daily personnel and environmental monitoring when sterile products are made, and growth promotion testing for environmental sampling is not based on a scientific method.

3. **Personnel Clothing:** Clothing for personnel engaged in manufacturing, processing, packing, and holding drug products is inappropriate. Personnel were observed putting on protective apparel in a non-classified area and then performing aseptic operations without further actions to prevent contamination, which violates written procedures and proper aseptic techniques. Additionally, masks and head covers worn are not labeled as sterile or non-shedding.

4. **Stability Testing Program:** There is no written testing program to assess drug product stability characteristics.