# FDA 483 - Tri-Med, Inc. dba Advanced Care Infusion-Shelby - February 23, 2015

Source: https://www.keypedia.com/records/483/tri-med-inc-dba-advanced-care-infusion-shelby/5dccdfe4-d0c9-4a94-9329-8bff22bacceb

> FDA 483 for Tri-Med, Inc. dba Advanced Care Infusion-Shelby on February 23, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tri-Med, Inc. dba Advanced Care Infusion-Shelby
- Inspection Date: 2015-02-23
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: This FDA Form 483 document outlines several deficiencies observed during an inspection of a facility involved in aseptic processing of sterile drug products.

**Key Observations:**

*   **Inadequate Investigations:** For multiple discrepancies and out-of-specification results, investigations were deemed inadequate due to the lack of immediate remediation and/or appropriate corrective actions.
*   **Aseptic Process Simulations (Media Fills):** The facility failed to perform adequate aseptic process simulations (media fills) under representative worst-case aseptic processing conditions, which is critical for assuring the sterility of drug products.
*   **Cleaning and Sanitization:** Cleaning and sanitization activities in aseptic processing areas were found to be inadequate.
*   **Environmental Monitoring:** The active viable environmental monitoring (EM) program at the facility was deemed inadequate.
*   **Facility Design Deficiencies:** Aseptic processing areas exhibited deficiencies in their physical design, specifically that floors, walls, and ceilings did not consist of smooth, easily cleanable surfaces.
*   **Air Filtration and Pressure:** Aseptic processing areas were deficient regarding air supply, as it was not consistently filtered through high-efficiency particulate air filters under positive pressure.
*   **Personnel Gowning:** The gowning procedures for personnel performing aseptic operations were found to be inadequate.
*   **Sterility Testing:** Not all lots of sterile product aseptically processed were tested for sterility.

These observations indicate significant issues within the facility's quality system

## Related Documents

- [483 - 2015-02-23](https://www.keypedia.com/records/483/tri-med-inc-dba-advanced-care-infusion-shelby/04ae4cdf-6918-446d-8206-4717f57e13d0)
- [WARNING_LETTER - 2015-02-23](https://www.keypedia.com/records/warning_letter/tri-med-inc-dba-advanced-care-infusion-shelby/0c9fc5ae-62fb-4a00-8546-796a8127fc68)
- [483 - 2017-07-11](https://www.keypedia.com/records/483/tri-med-inc-dba-advanced-care-infusion-shelby/4e81f5d3-361e-4d97-8197-709a7da43710)
- [STATE_REFERRAL_LETTER - 2017-06-26](https://www.keypedia.com/records/state_referral_letter/tri-med-inc-dba-advanced-care-infusion-shelby/90abe4e7-fa98-47e4-9ca5-a457272d566a)

## Related Officers

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

Company: https://www.keypedia.com/companies/tri-med-inc-dba-advanced-care-infusion-shelby/0678e8c0-b6c7-42ce-8f77-e4227559803b

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