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

Source: https://www.keypedia.com/records/483/total-vein-pharmacy/e2eee34b-021d-4288-8099-64c2ce3a67b6

> 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: Center for Drug Evaluation and Research
- Summary: On May 9, 2019, the FDA issued a Form 483 to Total Vein Pharmacy LLC dba Total Vein Pharmacy, located at 2428 Yale Street Suite B, Houston, TX 77008. The inspection, conducted on various dates between March 11 and May 9, 2019, identified three observations for the producer of sterile and non-sterile drugs.

Observation #1 noted that the ISO 5 classified areas were not certified under dynamic conditions, specifically lacking verification of unidirectional airflow under operational conditions. A smoke study from November 7, 2018, showed significant air turbulence in the ISO 5 area, which the firm failed to investigate.

Observation #2 stated that media fills did not adequately simulate aseptic production operations, failing to incorporate worst-case activities and conditions. A media fill dated September 28, 2018, involved (b)(4) vials, while actual production, such as Polidocanol 5% for Injection lot #5P021819 on February 18, 2019, routinely involved at least (b)(4) vials, or approximately (b)(4) vials.

Observation #3 indicated that the firm uses (b)(4) Cleaner and (b)(4) as disinfectants in the ISO 5 area, but the specified contact time of minutes has not been

## Related Documents

- [483 - 2019-05-09](https://www.keypedia.com/records/483/total-vein-pharmacy/d5e87a3f-d267-4c56-a327-17b59519e770)

## 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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c