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

Source: https://www.keypedia.com/records/483/health-dimensions-inc/da1e9ba7-36e8-43cc-ab69-6fdef0bbff01

> FDA 483 for Health Dimensions, Inc. on August 08, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Dimensions, Inc.
- Inspection Date: 2014-08-08
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: 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.,

## Related Documents

- [OTHER_CORRESPONDENCE - 2014-08-04](https://www.keypedia.com/records/other_correspondence/health-dimensions-inc/215dcd34-c739-4f10-ba2c-8a3149516d8d)
- [483_RESPONSE - 2014-08-08](https://www.keypedia.com/records/483_response/health-dimensions-inc/2b127645-82ae-4b3f-9bfc-959704fdf929)

## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)

Company: https://www.keypedia.com/companies/health-dimensions-inc/7f5414ab-0654-45a7-a536-dde7358170f5

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03