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

Source: https://www.keypedia.com/records/483/family-pharmacy-of-statesville/33fa907a-83e6-477f-858d-4e043e6cd684

> 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: Florida District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility producing sterile and non-sterile drug products, including those for injection and intrathecal administration.

**Sterile Product Deficiencies:**
*   **Cleaning and Disinfection:** Sporicidal agents were not used in cleanrooms or ISO 5 aseptic processing areas, and the cleaning log did not indicate their use. Disinfecting agents and wipes used in ISO 5 areas were not sterile; an expired, mislabeled, and reused spray bottle was found.
*   **Environmental Control:** Viable air sampling in ISO 5 hoods recovered *Staphylococcus spp.* and *Micrococcus/Kocuria spp.* Facility design allowed poor quality air into higher classified areas, with visible dust in an unclassified pass-through to an ISO 7 buffer room and an ISO 7 return air vent lacking HEPA filtration.
*   **Product Testing:** No endotoxin testing was performed for intrathecal drug products or their non-sterile starting materials/APIs, specifically for morphine sulfate buprenorphine 20 mg/4mg for intrathecal injection lot 01272020@6.
*   **Aseptic Processing:** Media fills did not adequately simulate aseptic production or incorporate worst-case conditions.
*   **Hazardous Drug Handling:** Hazardous drugs (e.g., fluorouracil, vancomycin) were produced without adequate containment, segregation, or

## Related Documents

- [483 - 2020-02-12](https://www.keypedia.com/records/483/family-pharmacy-of-statesville/bf9e8a91-fd05-47cb-b5c3-5783964cae5d)
- [483 - 2022-03-11](https://www.keypedia.com/records/483/family-pharmacy-of-statesville/6f86481d-1b8b-48f7-8bcc-f118b686f840)
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## 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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9