# FDA 483 - Total Vein Pharmacy - May 09, 2019

Source: https://www.keypedia.com/records/483/total-vein-pharmacy/d5e87a3f-d267-4c56-a327-17b59519e770

> FDA 483 for Total Vein Pharmacy on May 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Total Vein Pharmacy
- Inspection Date: 2019-05-09
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Total Vein Pharmacy LLC dba Total Vein Pharmacy in Houston, TX, a producer of sterile and non-sterile drugs, was cited for three observations during an FDA inspection. The observations relate to deficiencies in the certification of ISO 5 classified areas, inadequate media fill simulations for aseptic production, and unsubstantiated contact times for disinfectants used in the ISO 5 area. These issues indicate concerns with environmental control and aseptic processing procedures.

## Related Documents

- [483 - 2019-05-09](https://www.keypedia.com/records/483/total-vein-pharmacy/e2eee34b-021d-4288-8099-64c2ce3a67b6)

## Related Officers

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

Company: https://www.keypedia.com/companies/total-vein-pharmacy/b4d7ecb5-f954-4e68-be0a-be547f3327f7

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