Novel Laboratories, Inc. d,b.a LUPIN
Form 483 issued November 5, 2020 · Somerset, New Jersey
- Inspection
- Sep 10, 2020
- Investigators
- Ko U. Min· Lata Mathew· Saleem A. Akhtar
- Observations
- 13
- Pages
- 39
- FEI number
- 3006271436
In short: On November 5, 2020, FDA issued a Form 483 with 13 observations to Novel Laboratories, Inc. d,b.a LUPIN in Somerset, New Jersey (FEI 3006271436) after an inspection that ran Sep 10, 2020. The investigators were Ko U. Min, Lata Mathew, Saleem A. Akhtar and Unnee Ranjan. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 9 of 12 observations.
Most cited: 21 CFR 211.67 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 02
REPEAT OBSERVATION There is a failure to thoroughly review any unexplained discrepancy and the failure of…
- 03
The written stability program…
- 04
The accuracy and sensitivity of test methods…
This inspection in context
Ko U. Min
13 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New Jersey.
The firmNovel Laboratories, Inc. d,b.a LUPIN history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novel Laboratories, Inc. d,b.a LUPIN?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Novel Laboratories, Inc. d,b.a LUPIN?
Ko U. Min, Lata Mathew, Saleem A. Akhtar and Unnee Ranjan are named on this Form 483, for the inspection of Sep 10, 2020. Each investigator has a profile showing what they cite most.
When was Novel Laboratories, Inc. d,b.a LUPIN inspected by FDA?
The inspection ran Sep 10, 2020, and the Form 483 is dated November 5, 2020.
How do I get the full Form 483 for Novel Laboratories, Inc. d,b.a LUPIN?
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.