# FDA 483 - Vital Care Compounder, Inc - October 13, 2022

Source: https://www.globalkeysolutions.net/records/483/vital-care-compounder-inc/987d548e-616d-48f6-8c3d-012755b91a68

> FDA 483 for Vital Care Compounder, Inc on October 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vital Care Compounder, Inc
- Inspection Date: 2022-10-13
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, MS, revealed significant deficiencies in the production of sterile and non-sterile drug products. Observations included microbial contamination in aseptic areas, inadequate sterilization processes, poor facility and personnel aseptic practices, and insufficient media fills. These issues indicate a high risk of product contamination and compromise of sterility assurance.

## Related Documents

- [483 - 2016-07-07](https://www.globalkeysolutions.net/records/483/vital-care-compounder-inc/edd26f5b-7914-4083-ae90-49ae18ca66fd)
- [483 - 2019-05-16](https://www.globalkeysolutions.net/records/483/vital-care-compounder-inc/d4574378-a5f1-47bb-b61e-264f04446e6b)
- [483 - 2022-10-13](https://www.globalkeysolutions.net/records/483/vital-care-compounder-inc/2c09e4fd-588a-4815-8f24-8f89aed257a2)

## Related Officers

- [Pharmacy Compounding National Expert at FDA](https://www.globalkeysolutions.net/people/jessica-p-mcalister/d892c069-d283-4bb0-9cbb-78e463bfc1ea)
- [Program Coordinator](https://www.globalkeysolutions.net/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)
- [Owner/Inspector](https://www.globalkeysolutions.net/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)

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

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea