Q-Med AB
Form 483 issued March 27, 2026 · Uppsala, Sweden
- Inspection
- Mar 16 – Mar 27, 2026
- Investigator
- Olumide Martins
- Observations
- 11
- Pages
- 16
- FEI number
- 3003347293
In short: On March 27, 2026, FDA issued a Form 483 with 11 observations to Q-Med AB in Uppsala, Uppland (FEI 3003347293) after an inspection that ran Mar 16 – Mar 27, 2026. The investigator was Olumide Martins.
What FDA observed
Preview: the opening words of each observation- 01
The firm’s contamination control strategy does not provide…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The environmental monitoring program is not adequate to ensure that the manufacturing areas for oO@ DS…
- 04
Procedures designed to simulate aseptic processes are inadequate to assure the sterility…
This inspection in context
Olumide Martins
2 documents · 2024–2026
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Germany.
The firmQ-Med AB history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Q-Med AB?
FDA listed 11 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Q-Med AB?
Olumide Martins is named on this Form 483, for the inspection of Mar 16 – Mar 27, 2026. Each investigator has a profile showing what they cite most.
When was Q-Med AB inspected by FDA?
The inspection ran Mar 16 – Mar 27, 2026, and the Form 483 is dated March 27, 2026.
How do I get the full Form 483 for Q-Med AB?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.