> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Wells Pharma Hit With 483 After Inspection
- URL: https://www.fdaweb.com/wells-pharma-hit-with-483-after-inspection/
- Published: 2022-02-04T12:00:00.000Z
- Updated: 2026-09-14T17:31:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151081

FDA has issued Wells Pharma (Houston, TX) a one-item Form FDA-483 after a 6/2021 inspection at the drug outsourcing facility. The inspection cited the firm’s procedures designed to prevent microbiological contamination of sterile drug products because they are not established, written and followed, according to the [inspectional observation form](https://www.fda.gov/media/155873/download?ref=fdaweb.com). “Specifically, there is no assurance that unidirectional airflow is maintained in the ISO 5 laminar air flow workbenches where sterile, injectable drug products are compounded,” it said.