Novitium Pharma LLC
FDA inspection history in East Windsor, New Jersey, 2019 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at East Windsor, New Jersey.
- 2019The longest 483 on file: 3 observations over 2 pages at East Windsor, New Jersey.
Cited most
Across all Novitium Pharma observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Novitium Pharma file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
East Windsor, New Jersey
Two Form 483s · 2019 to 2021 · 4 observations
Latest: Form 483, Jul 8, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-08 | 483 Form 483 | East Windsor, New Jersey | 1 | $99 |
| 2019-02-04 | 483 Form 483 | East Windsor, New Jersey | 3 | $99 |
Investigators on these documents
FEI number 3012541241 · most recent document Jul 8, 2021
About Novitium Pharma LLC
How many FDA Form 483s has Novitium Pharma LLC received?
FDA Intel has 2 Form 483s on file for Novitium Pharma LLC; the most recent is dated Jul 8, 2021.
When was Novitium Pharma LLC last inspected by FDA?
The most recent FDA inspection document on file for Novitium Pharma LLC is a Form 483 dated Jul 8, 2021, for the site in East Windsor, New Jersey.
What did FDA cite at Novitium Pharma LLC?
The regulations cited most in the observations on file for Novitium Pharma LLC are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.