# FDA 483 - Vital Care Compounder, Inc - May 16, 2019

Source: https://www.keypedia.com/records/483/vital-care-compounder-inc/d4574378-a5f1-47bb-b61e-264f04446e6b

> FDA 483 for Vital Care Compounder, Inc on May 16, 2019. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Vital Care Compounder, Inc
- Inspection Date: 2019-05-16
- Product Type: Drugs
- Summary: The FDA Form 483 documents deficiencies at a facility involved in drug product manufacturing, processing, packing, and holding. Several observations are repeat findings.

**Environmental Monitoring and Aseptic Conditions:**
*   Environmental monitoring, including personnel monitoring, is only conducted every (b)(4).
*   Pressure in classified rooms has not been monitored or documented since December 2018.
*   Cleaning records prior to January 2019 are absent and lack contact times for cleaning agents. Triple cleaning after growth in ISO 7 rooms (March 2017, September 2017, March 2018) is not documented.
*   Non-sterile (b)(4) product is used to clean ISO 5 (b)(4) and laminar flow hoods.
*   Non-sterile wipes and mop covers are used in classified areas, including inside the (b)(4) and laminar flow hood.

**Personnel and Facility Deficiencies:**
*   Personnel clothing (gown, mask, hairnet, booties) used in classified areas is not sterile.
*   The anteroom (ISO 7) is crowded, hindering operations.
*   Rust is present on the anteroom floor.
*   No written procedures exist for handling spills or cleaning hazardous drugs/blood-derived components.
*   Scales for non-sterile products have dirt and rust stains; spatulas are worn, stained,

## Related Documents

- [483 - 2016-07-07](https://www.keypedia.com/records/483/vital-care-compounder-inc/edd26f5b-7914-4083-ae90-49ae18ca66fd)
- [483 - 2022-10-13](https://www.keypedia.com/records/483/vital-care-compounder-inc/987d548e-616d-48f6-8c3d-012755b91a68)
- [483 - 2022-10-13](https://www.keypedia.com/records/483/vital-care-compounder-inc/2c09e4fd-588a-4815-8f24-8f89aed257a2)

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.keypedia.com/companies/vital-care-compounder-inc/2010dd7b-a5d9-48e3-b5b4-e0d3fd9aacd1