Novel Laboratories, Inc.
Form 483 issued April 17, 2026 · Somerset, New Jersey
- Inspection
- Apr 13 – Apr 17, 2026
- Investigators
- Anthony Donato· Daniel T. Lee
- Observations
- 3
- Pages
- 6
- FEI number
- 3006271438
In short: On April 17, 2026, FDA issued a Form 483 with 3 observations to Novel Laboratories, Inc. in Somerset, New Jersey (FEI 3006271438) after an inspection that ran Apr 13 – Apr 17, 2026. The investigators were Anthony Donato and Daniel T. Lee. Most observations concern quality system and materials.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
The number of containers to be sampled and amount of material taken from each container is…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Anthony Donato
6 documents · 2020–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmNovel Laboratories, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novel Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.
Who inspected Novel Laboratories, Inc.?
Anthony Donato and Daniel T. Lee are named on this Form 483, for the inspection of Apr 13 – Apr 17, 2026. Each investigator has a profile showing what they cite most.
When was Novel Laboratories, Inc. inspected by FDA?
The inspection ran Apr 13 – Apr 17, 2026, and the Form 483 is dated April 17, 2026.
How do I get the full Form 483 for Novel Laboratories, 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.