Dharma Research, Inc.
Form 483 issued December 11, 2024 · Miami, Florida
- Inspection
- Dec 9 – Dec 11, 2024
- Investigator
- Ronald Ifraimov
- Observations
- 3
- Pages
- 4
- FEI number
- 3010131268
In short: On December 11, 2024, FDA issued a Form 483 with 3 observations to Dharma Research, Inc. in Miami, Florida (FEI 3010131268) after an inspection that ran Dec 9 – Dec 11, 2024. The investigator was Ronald Ifraimov. Most observations concern design controls and records & documents.
At a glance
Design controls and records & documents account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The results of design validation, including identification of the design, method(s), the date and the individual(s)…
- 02
The device history record does not demonstrate that the device was manufactured in accordance with…
- 03
Corrective and preventive action activities and/or results…
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.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dharma Research, Inc.?
FDA listed 3 observations on this Form 483, mostly about design controls, records & documents and cAPA. 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 Dec 9 – Dec 11, 2024. Each investigator has a profile showing what they cite most.
When was Dharma Research, Inc. inspected by FDA?
The inspection ran Dec 9 – Dec 11, 2024, and the Form 483 is dated December 11, 2024.
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.