# FDA 483 - Family Pharmacy of Statesville - February 12, 2020

Source: https://www.keypedia.com/records/483/family-pharmacy-of-statesville/bf9e8a91-fd05-47cb-b5c3-5783964cae5d

> FDA 483 for Family Pharmacy of Statesville on February 12, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Family Pharmacy of Statesville
- Inspection Date: 2020-02-12
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Family Pharmacy of Statesville was inspected and cited for multiple deficiencies in both sterile and non-sterile drug production. Key issues include inadequate aseptic processing controls, lack of endotoxin testing for intrathecal products, facility design flaws, and insufficient quality control for water and equipment calibration. These observations indicate significant concerns regarding the sterility assurance and overall quality of drug products manufactured at the facility.

## Related Documents

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- [483 - 2022-03-11](https://www.keypedia.com/records/483/family-pharmacy-of-statesville/87047c90-aba4-4656-b62e-33278cc42f9b)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/family-pharmacy-of-statesville/559ac6a1-756f-4c29-8a0e-65f8bb04cd61

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6