# FDA 483 - ApotheCure Inc - August 13, 2007

Source: https://www.keypedia.com/records/483/apothecure-inc/5177f5f7-e0b6-4268-8e72-f742d32334c2

> FDA 483 for ApotheCure Inc on August 13, 2007. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ApotheCure Inc
- Inspection Date: 2007-08-13
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

## Related Officers

- [Supervisory ](https://www.keypedia.com/people/tricia-samaniego-martinez/3754a4fb-1dc9-49bc-96c8-75a30f3dabda)
- [Acting Program Division Director ](https://www.keypedia.com/people/charles-d-brown/8b817b44-437e-476c-b2b2-1c4c6e7e7b54)
- [Compliance Officer](https://www.keypedia.com/people/jeffrey-r-wooley/f46f663f-0f2e-4a07-98aa-ecaa43aace35)

Company: https://www.keypedia.com/companies/apothecure-inc/dc57bcd3-9b52-4749-b378-8dc18c5c55d0

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9