Novel Laboratories, Inc.
Form 483 issued January 13, 2023 · Somerset, New Jersey
- Inspection
- Jan 4 – Jan 13, 2023
- Investigator
- Karishma G. Gopaul
- Observations
- 2
- Pages
- 4
- FEI number
- 3006271438
In short: On January 13, 2023, FDA issued a Form 483 with 2 observations to Novel Laboratories, Inc. in Somerset, New Jersey (FEI 3006271438) after an inspection that ran Jan 4 – Jan 13, 2023. The investigator was Karishma G. Gopaul. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Karishma G. Gopaul
8 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novel Laboratories, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Novel Laboratories, Inc.?
Karishma G. Gopaul is named on this Form 483, for the inspection of Jan 4 – Jan 13, 2023. Each investigator has a profile showing what they cite most.
When was Novel Laboratories, Inc. inspected by FDA?
The inspection ran Jan 4 – Jan 13, 2023, and the Form 483 is dated January 13, 2023.
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.