Galaxy Medical Products LLC
Form 483 issued April 28, 2026 · Medina
- Inspection
- Apr 27 – Apr 28, 2026
- Investigator
- Supreet K. Sran
- Observations
- 1
- Pages
- 2
In short: On April 28, 2026, FDA issued a Form 483 with 1 observation to Galaxy Medical Products LLC in Medina after an inspection that ran Apr 27 – Apr 28, 2026. The investigator was Supreet K. Sran. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that no errors have…
This inspection in context
Questions about this 483
What did FDA find at Galaxy Medical Products LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Galaxy Medical Products LLC?
Supreet K. Sran is named on this Form 483, for the inspection of Apr 27 – Apr 28, 2026. Each investigator has a profile showing what they cite most.
When was Galaxy Medical Products LLC inspected by FDA?
The inspection ran Apr 27 – Apr 28, 2026, and the Form 483 is dated April 28, 2026.
How do I get the full Form 483 for Galaxy Medical Products LLC?
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.