NanoHive Medical LLC
Form 483 issued March 5, 2026 · Woburn, Massachusetts
- Inspection
- Mar 2 – Mar 5, 2026
- Investigator
- Nabil Nakhoul
- Observations
- 1
- Pages
- 3
- FEI number
- 3013462427
In short: On March 5, 2026, FDA issued a Form 483 with 1 observation to NanoHive Medical LLC in Woburn, Massachusetts (FEI 3013462427) after an inspection that ran Mar 2 – Mar 5, 2026. The investigator was Nabil Nakhoul. The most-cited regulation is 21 CFR 8.2.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 8.2.2
Complaint handling records were…
This inspection in context
Nabil Nakhoul
4 documents · 2023–2026
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNanoHive Medical LLC history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at NanoHive Medical LLC?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 8.2. The opening words of each observation are shown on this page.
Who inspected NanoHive Medical LLC?
Nabil Nakhoul is named on this Form 483, for the inspection of Mar 2 – Mar 5, 2026. Each investigator has a profile showing what they cite most.
When was NanoHive Medical LLC inspected by FDA?
The inspection ran Mar 2 – Mar 5, 2026, and the Form 483 is dated March 5, 2026.
How do I get the full Form 483 for NanoHive Medical 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.