Navinta LLC
FDA inspection history in Ewing, New Jersey, 2016 to 2023
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: one warning letter; 2018: one close-out letter; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19One warning letter, one close-out letter and one Form 483, at Ewing, New Jersey.
- 2023One Form 483, at Ewing, New Jersey.
- 2023The longest 483 on file: 5 observations over 5 pages at Ewing, New Jersey.
Cited most
Across all Navinta observations on file
- 21 CFR 314.80(d)Postmarketing reporting of adverse drug experiences1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.30Design controls1
- 21 CFR 820.50Purchasing controls1
The complete Navinta file.
All 4 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
Ewing, New Jersey
Two Form 483s and one warning letter · 2016 to 2023 · 6 observations
Latest: Form 483, Jun 29, 2023 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-29 | 483 Form 483 | Ewing, New Jersey | 5 | $99 |
| 2019-03-28 | 483 Form 483 | Ewing, New Jersey | 1 | $99 |
| 2018-03-05 | Close-out Close-out letter | — | — | $99 |
| 2016-09-26 | Warning letter Warning letter | Ewing, New Jersey | — | $99 |
Investigators on these documents
FEI number 3004375014 · most recent document Jun 29, 2023
About Navinta LLC
How many FDA Form 483s has Navinta LLC received?
FDA Intel has 2 Form 483s on file for Navinta LLC; the most recent is dated Jun 29, 2023.
When was Navinta LLC last inspected by FDA?
The most recent FDA inspection document on file for Navinta LLC is a Form 483 dated Jun 29, 2023, for the site in Ewing, New Jersey.
What did FDA cite at Navinta LLC?
The regulations cited most in the observations on file for Navinta LLC are 21 CFR 314.80(d) (Postmarketing reporting of adverse drug experiences), 1 time; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.22 (Quality audit), 1 time.
Has Navinta LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Navinta LLC; the most recent is dated Sep 26, 2016.