Novel Laboratories, Inc. d,b.a LUPIN
FDA inspection history in Somerset, New Jersey, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Somerset, New Jersey.
Cited most
Across all Novel Laboratories, Inc. d,b.a LUPIN observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
The complete Novel Laboratories, Inc. d,b.a LUPIN file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Somerset, New Jersey
One Form 483 · 2020 · 13 observations
Latest: Form 483, Nov 5, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-11-05 | 483 Form 483 | Somerset, New Jersey | 13 | $99 |
Investigators on these documents
Ko U. Min (1)Lata Mathew (1)Saleem A. Akhtar (1)Unnee Ranjan (1)
FEI number 3006271436 · most recent document Nov 5, 2020
About Novel Laboratories, Inc. d,b.a LUPIN
How many FDA Form 483s has Novel Laboratories, Inc. d,b.a LUPIN received?
FDA Intel has 1 Form 483 on file for Novel Laboratories, Inc. d,b.a LUPIN; the most recent is dated Nov 5, 2020.
When was Novel Laboratories, Inc. d,b.a LUPIN last inspected by FDA?
The most recent FDA inspection document on file for Novel Laboratories, Inc. d,b.a LUPIN is a Form 483 dated Nov 5, 2020, for the site in Somerset, New Jersey.
What did FDA cite at Novel Laboratories, Inc. d,b.a LUPIN?
The regulations cited most in the observations on file for Novel Laboratories, Inc. d,b.a LUPIN are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.