Waylis Therapeutics LLC
Form 483 issued February 12, 2026 · Rahway, New Jersey
- Inspection
- Feb 9 – Feb 12, 2026
- Investigator
- Mayar M. Mussa
- Observations
- 1
- Pages
- 2
- FEI number
- 3021614574
In short: On February 12, 2026, FDA issued a Form 483 with 1 observation to Waylis Therapeutics LLC in Rahway, New Jersey (FEI 3021614574) after an inspection that ran Feb 9 – Feb 12, 2026. The investigator was Mayar M. Mussa. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Written procedures have not been developed for the surveillance of post…
This inspection in context
Mayar M. Mussa
1 document · 2026
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in New Jersey.
The firmWaylis Therapeutics LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Waylis Therapeutics LLC?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Waylis Therapeutics LLC?
Mayar M. Mussa is named on this Form 483, for the inspection of Feb 9 – Feb 12, 2026. Each investigator has a profile showing what they cite most.
When was Waylis Therapeutics LLC inspected by FDA?
The inspection ran Feb 9 – Feb 12, 2026, and the Form 483 is dated February 12, 2026.
How do I get the full Form 483 for Waylis Therapeutics 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.