FDA 483 - ApotheCure Inc - August 13, 2007

The FDA Form 483 details numerous violations at a drug compounding facility, ApotheCure Inc., related to sterile injectable drug products and overall quality control.

**Facility and Operations:** The firm compounds sterile injectables like DMPS, EDTA Disodium, and Prolotherapy AQ 1%, along with capsules and creams. The Ante Room and Laminar Airflow Workbench (LAFW) are critical areas for sterile compounding.

**Violations and Observations:**

* **Sterility Testing & Pyrogen Testing:** Only a limited sample from sterile injectable batches is sent for sterility analysis, regardless of batch size. No pyrogen testing is conducted. * **Sterilization Process Validation:** * No evaluation of the Ante Room or LAFW for airborne microorganisms (e.g., weekly). * Sterilization processes for glass vials, stoppers, scoops, and finished injectables (e.g., DHEA, Hyaluronic Acid) lack documented validation. * Sterile filling processes for all injectable products (e.g., Calcium-Disodium EDTA, DMPS) lack documented effectiveness. * Cleaning regimens for equipment and LAFW lack documented effectiveness. * **Microbiological Contamination Prevention:** * Procedures for controlling contamination in the Ante Room are inadequate. * Employees gown up in an uncontrolled environment outside the Ante Room. * An insect trap and a portable radio were observed in