Dharma Research, Inc.
Form 483 issued March 13, 2026 · Miami, Florida
- Inspection
- Mar 11 – Mar 13, 2026
- Investigator
- Ronald Ifraimov
- Observations
- 1
- Pages
- 3
- FEI number
- 3010131268
In short: On March 13, 2026, FDA issued a Form 483 with 1 observation to Dharma Research, Inc. in Miami, Florida (FEI 3010131268) after an inspection that ran Mar 11 – Mar 13, 2026. The investigator was Ronald Ifraimov. The most-cited regulation is 21 CFR 7.1 (scope).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization have…
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 firmDharma Research, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Dharma Research, Inc.?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 7.1 (scope). The opening words of each observation are shown on this page.
Who inspected Dharma Research, Inc.?
Ronald Ifraimov is named on this Form 483, for the inspection of Mar 11 – Mar 13, 2026. Each investigator has a profile showing what they cite most.
When was Dharma Research, Inc. inspected by FDA?
The inspection ran Mar 11 – Mar 13, 2026, and the Form 483 is dated March 13, 2026.
How do I get the full Form 483 for Dharma Research, Inc.?
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.