CSA Medical, Inc
Form 483 issued March 23, 2026 · Lexington, Massachusetts
- Inspection
- Mar 17 – Mar 23, 2026
- Investigators
- Nabil Nakhoul· Thomas Siebertz
- Observations
- 1
- Pages
- 3
- FEI number
- 3010140265
In short: On March 23, 2026, FDA issued a Form 483 with 1 observation to CSA Medical, Inc in Lexington, Massachusetts (FEI 3010140265) after an inspection that ran Mar 17 – Mar 23, 2026. The investigators were Nabil Nakhoul and Thomas Siebertz. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.90 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation…
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 firmCSA Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CSA Medical, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected CSA Medical, Inc?
Nabil Nakhoul and Thomas Siebertz are named on this Form 483, for the inspection of Mar 17 – Mar 23, 2026. Each investigator has a profile showing what they cite most.
When was CSA Medical, Inc inspected by FDA?
The inspection ran Mar 17 – Mar 23, 2026, and the Form 483 is dated March 23, 2026.
How do I get the full Form 483 for CSA Medical, 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.