Hovione LLC
FDA inspection history in East Windsor, New Jersey, 2020 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–22Three Form 483s, at East Windsor, New Jersey.
- 2021The longest 483 on file: 8 observations over 23 pages at East Windsor, New Jersey.
Cited most
Across all Hovione observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.80General requirements2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
The complete Hovione file.
All 3 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
Three Form 483s · 2020 to 2022 · 11 observations
Latest: Form 483, Nov 17, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-17 | 483 Form 483 | East Windsor, New Jersey | 1 | $99 |
| 2021-05-28 | 483 Form 483 | East Windsor, New Jersey | 8 | $99 |
| 2020-01-22 | 483 Form 483 | East Windsor, New Jersey | 2 | $99 |
Investigators on these documents
Adetutu Gidado (2)Robin P. Mathew (2)Annet R. Rajan (1)Saleem A. Akhtar (1)Stelios C. Tsinontides (1)
FEI number 3006106736 · most recent document Nov 17, 2022
About Hovione LLC
How many FDA Form 483s has Hovione LLC received?
FDA Intel has 3 Form 483s on file for Hovione LLC; the most recent is dated Nov 17, 2022.
When was Hovione LLC last inspected by FDA?
The most recent FDA inspection document on file for Hovione LLC is a Form 483 dated Nov 17, 2022, for the site in East Windsor, New Jersey.
What did FDA cite at Hovione LLC?
The regulations cited most in the observations on file for Hovione LLC are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.25 (Personnel qualifications), 2 times; 21 CFR 211.80 (General requirements), 2 times.