Novel Laboratories, Inc.
Form 483 issued March 30, 2022 · Somerset, New Jersey
- Inspection
- Mar 7 – Mar 30, 2022
- Investigators
- Adetutu Gidado· Ko U. Min· Sandra A. Boyd
- Observations
- 13
- Pages
- 13
- FEI number
- 3006271438
In short: On March 30, 2022, FDA issued a Form 483 with 13 observations to Novel Laboratories, Inc. in Somerset, New Jersey (FEI 3006271438) after an inspection that ran Mar 7 – Mar 30, 2022. The investigators were Adetutu Gidado, Ko U. Min and Sandra A. Boyd. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 10 of 13 observations.
Most cited: 21 CFR 211.68 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug product are…
- 04
Employees engaged in the manufacture, processing and packing of a drug product lack the training required…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novel Laboratories, Inc.?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Novel Laboratories, Inc.?
Adetutu Gidado, Ko U. Min and Sandra A. Boyd are named on this Form 483, for the inspection of Mar 7 – Mar 30, 2022. Each investigator has a profile showing what they cite most.
When was Novel Laboratories, Inc. inspected by FDA?
The inspection ran Mar 7 – Mar 30, 2022, and the Form 483 is dated March 30, 2022.
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.