# FDA 483 - Vann Healthcare Services Inc - September 24, 2014

Source: https://www.keypedia.com/records/483/vann-healthcare-services-inc/a94815ca-97e8-4141-a59f-1e975d1090d1

> FDA 483 for Vann Healthcare Services Inc on September 24, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vann Healthcare Services Inc
- Inspection Date: 2014-09-24
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: An FDA Form 483 was issued following an inspection on September 10, 2014, identifying several deficiencies in the facility's operations related to sterile drug product manufacturing.

**Violations and Observations:**

1.  **Personnel Clothing:** An operator performing aseptic manipulations in an ISO 5 laminar flow hood wore a non-sterile gown that did not adequately cover wrists or the upper chest, failing to meet appropriate clothing standards for duties.

2.  **Sterilization Process Validation:**
    *   Sterilization processes for Lidocaine 4% injectable and Hydroxyprogesterone caproate injection were not validated.
    *   The sterilization process for stoppers used with Hydroxyprogesterone caproate injection 250 mg/ml was not validated.
    *   Media fills were not conducted to validate aseptic processes in the ISO 5 laminar flow hood.
    *   Endotoxin testing was not performed for products sterilized by filtration.

3.  **Microbiological Contamination Testing:** No sterility or endotoxin test data existed for Lidocaine 4% injectable (60-day refrigerated BUD), Epinephrine 1:1000 injection (30-day room temperature BUD), or Hydroxyprogesterone caproate injection, 250 mg/ml (90-day room temperature BUD).

4.  **Stability Testing Program:** No written program or potency test data supported the assigned beyond-

## Related Documents

- [WARNING_LETTER - 2014-09-24](https://www.keypedia.com/records/warning_letter/vann-healthcare-services-inc/f10a108a-bd5c-4e53-948f-4677b48f9699)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kathleen-dant-culver/fe43f228-7c7a-47ea-94cb-349324553012)

Company: https://www.keypedia.com/companies/vann-healthcare-services-inc/8ad49d3f-9bdb-4e97-9b9d-d4164d82e5ab

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22