# FDA 483 - Family Pharmacy of Statesville - March 11, 2022

Source: https://www.keypedia.com/records/483/family-pharmacy-of-statesville/6f86481d-1b8b-48f7-8bcc-f118b686f840

> FDA 483 for Family Pharmacy of Statesville on March 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Family Pharmacy of Statesville
- Inspection Date: 2022-03-11
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Family Pharmacy of Statesville, Inc. revealed multiple critical deficiencies in aseptic processing and environmental controls for sterile drug production. Observations included inadequate material handling, insufficient disinfection practices, and failures in media fill simulations to challenge aseptic operations. The facility also lacked proper HEPA filtration, failed to verify sterilization cycles, and exhibited poor cleanroom design and maintenance, indicating a significant risk of contamination to sterile products.

## Related Documents

- [483 - 2020-02-12](https://www.keypedia.com/records/483/family-pharmacy-of-statesville/bf9e8a91-fd05-47cb-b5c3-5783964cae5d)
- [483 - 2020-02-12](https://www.keypedia.com/records/483/family-pharmacy-of-statesville/33fa907a-83e6-477f-858d-4e043e6cd684)
- [483 - 2022-03-11](https://www.keypedia.com/records/483/family-pharmacy-of-statesville/87047c90-aba4-4656-b62e-33278cc42f9b)

## Related Officers

- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)
- [Strategic Communications Specialist, Consumer Safety Officer](https://www.keypedia.com/people/lavalais-song/ea936f12-0c09-43db-895c-24bb2efa5a90)

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

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7