# FDA 483 - Strive Pharmacy Texas LLC dba Strive Pharmacy - November 02, 2021

Source: https://www.keypedia.com/records/483/strive-pharmacy-texas-llc-dba-strive-pharmacy/964d8085-adac-41e7-84d7-cf7b34fa6448

> FDA 483 for Strive Pharmacy Texas LLC dba Strive Pharmacy on November 02, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strive Pharmacy Texas LLC dba Strive Pharmacy
- Inspection Date: 2021-11-02
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 was issued to Vita Pharmacy, LLC dba Talon Pharmacy of Boerne, a producer of sterile drug products, located at 1430 South Main Street #105, Boerne, TX 78006. The inspection occurred from October 18-22, 25-27, 2021, and November 2, 2021.

The inspection revealed six observations:

1.  **Facility Design Deficiencies:** The facility design may allow poor quality air into higher classified areas. This includes a visible gap between the ceiling and a barrier separating ISO 5 and ISO 7 areas, (b)(4) doors lacking safeguards for differential pressure changes, a crack in the ISO 7 cleanroom wall allowing ingress from the ISO 8 area, and a power cord obstructing an exhaust vent between ISO 8 and ISO 7, allowing dust ingress.
2.  **Inadequate Hazardous Drug Containment:** Hazardous drugs were produced without adequate containment and segregation to prevent cross-contamination. The ISO 5 Biological Safety Cabinet for hazardous sterile drug products is located in the ISO 7 cleanroom, close to the ISO 5 workbench area.
3.  **Residue on HEPA Filter Grille:** A dark residue was observed on the plastic grille enclosing the HEPA filter in the ISO 5 workbench area.
4.  **Improper Material Disinfection

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## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

Company: https://www.keypedia.com/companies/strive-pharmacy-texas-llc-dba-strive-pharmacy/514dc63b-6e2b-4453-8c78-b15ae29c22ce

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9