Novel Laboratories, Inc.
Form 483 issued December 21, 2018 · Somerset, New Jersey
- Inspection
- Dec 3 – Dec 21, 2018
- Investigators
- Jogy George· Lata Mathew
- Observations
- 6
- Pages
- 14
- FEI number
- 3006271438
In short: On December 21, 2018, FDA issued a Form 483 with 6 observations to Novel Laboratories, Inc. in Somerset, New Jersey (FEI 3006271438) after an inspection that ran Dec 3 – Dec 21, 2018. The investigators were Jogy George and Lata Mathew. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
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
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jogy George
15 documents · 2016–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
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 6 observations on this Form 483, mostly about quality system, packaging & labeling and production. The opening words of each observation are shown on this page.
Who inspected Novel Laboratories, Inc.?
Jogy George and Lata Mathew are named on this Form 483, for the inspection of Dec 3 – Dec 21, 2018. Each investigator has a profile showing what they cite most.
When was Novel Laboratories, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 21, 2018, and the Form 483 is dated December 21, 2018.
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.