Lotte Biologics USA, LLC
FDA inspection history in East Syracuse, New York, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at East Syracuse, New York.
Cited most
Across all Lotte Biologics USA observations on file
- 21 CFR 211.192Production record review1
The complete Lotte Biologics USA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
East Syracuse, New York
One Form 483 · 2019
Latest: Form 483, Jun 5, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-05 | 483 Form 483 | East Syracuse, New York | — | $99 |
FEI number 1317757 · most recent document Jun 5, 2019
About Lotte Biologics USA, LLC
How many FDA Form 483s has Lotte Biologics USA, LLC received?
FDA Intel has 1 Form 483 on file for Lotte Biologics USA, LLC; the most recent is dated Jun 5, 2019.
When was Lotte Biologics USA, LLC last inspected by FDA?
The most recent FDA inspection document on file for Lotte Biologics USA, LLC is a Form 483 dated Jun 5, 2019, for the site in East Syracuse, New York.
What did FDA cite at Lotte Biologics USA, LLC?
The regulations cited most in the observations on file for Lotte Biologics USA, LLC are 21 CFR 211.192 (Production record review), 1 time.