USpharma Ltd
Form 483 issued May 11, 2023 · Miami Lake, Florida
- Inspection
- May 10 – May 11, 2023
- Investigator
- Ronald Ifraimov
- Observations
- 1
- Pages
- 3
- FEI number
- 1010370
In short: On May 11, 2023, FDA issued a Form 483 with 1 observation to USpharma Ltd in Miami Lake, Florida (FEI 1010370) after an inspection that ran May 10 – May 11, 2023. The investigator was Ronald Ifraimov. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Ronald Ifraimov
10 documents · 2014–2026
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Florida.
The firmUSpharma Ltd history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at USpharma Ltd?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected USpharma Ltd?
Ronald Ifraimov is named on this Form 483, for the inspection of May 10 – May 11, 2023. Each investigator has a profile showing what they cite most.
When was USpharma Ltd inspected by FDA?
The inspection ran May 10 – May 11, 2023, and the Form 483 is dated May 11, 2023.
How do I get the full Form 483 for USpharma Ltd?
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.