Dxn Pharmaceutical Sdn Bhd
Form 483 issued March 6, 2026
- Inspection
- Mar 3 – Mar 6, 2026
- Investigator
- Jackson Y. See
- Observations
- 1
- Pages
- 2
- FEI number
- 3006649152
In short: On March 6, 2026, FDA issued a Form 483 with 1 observation to Dxn Pharmaceutical Sdn Bhd (FEI 3006649152) after an inspection that ran Mar 3 – Mar 6, 2026. The investigator was Jackson Y. See. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.210 (what must the master manufacturing record include?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.210 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your master manufacturing record did not…
This inspection in context
Jackson Y. See
1 document · 2026
Cites 111.210 (what must the master manufacturing record include?) more than any other section.
The firmDxn Pharmaceutical Sdn Bhd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 111.210
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dxn Pharmaceutical Sdn Bhd?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.210 (what must the master manufacturing record include?). The opening words of each observation are shown on this page.
Who inspected Dxn Pharmaceutical Sdn Bhd?
Jackson Y. See is named on this Form 483, for the inspection of Mar 3 – Mar 6, 2026. Each investigator has a profile showing what they cite most.
When was Dxn Pharmaceutical Sdn Bhd inspected by FDA?
The inspection ran Mar 3 – Mar 6, 2026, and the Form 483 is dated March 6, 2026.
How do I get the full Form 483 for Dxn Pharmaceutical Sdn Bhd?
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.