# FDA 483 - Q-Med AB - March 27, 2026

Source: https://www.keypedia.com/records/483/q-med-ab/c2568e73-e2ad-4af7-8be3-5faa567bdf75

> FDA 483 for Q-Med AB on March 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Q-Med AB
- Inspection Date: 2026-03-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Q-Med AB in Uppsala, Sweden, a manufacturer of drug substance and drug product, received a Form FDA 483 with 11 observations. The inspection revealed significant deficiencies across contamination control, aseptic processing, environmental monitoring, quality systems, visual inspection, cleaning and disinfection, material control, and laboratory testing. These issues indicate a broad lack of adherence to cGMPs and inadequate quality oversight, posing risks to product quality and sterility.

## Related Officers

- [Jun Liu](https://www.keypedia.com/people/jun-liu/39e5d6f3-32fd-426f-880d-3d840a9faed2)
- [Qibing Zhou](https://www.keypedia.com/people/qibing-zhou/8461b502-5b9e-41af-ba90-f354c9f79d15)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)
- [Olumide A. Martins](https://www.keypedia.com/people/olumide-a-martins/e325adf8-64a0-426a-b22f-2503e41a3f5a)
- [Yan Liu, Ph.D.](https://www.keypedia.com/people/yan-liu-phd/c48a7232-e748-4a0a-98f2-b592cb1f578e)

Company: https://www.keypedia.com/companies/q-med-ab/032a27fc-d1ee-4ed3-98da-38090c026849

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8