Sucampo Pharma Limited Liability Company
FDA inspection history in SANDA, Japan, 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 SANDA, Japan.
Cited most
Across all Sucampo Pharma Limited Liability observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Sucampo Pharma Limited Liability file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
SANDA, Japan
One Form 483 · 2019 · 4 observations
Latest: Form 483, Aug 23, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-23 | 483 Form 483 | SANDA, Japan | 4 | $99 |
Investigators on these documents
FEI number 3004520523 · most recent document Aug 23, 2019
About Sucampo Pharma Limited Liability Company
How many FDA Form 483s has Sucampo Pharma Limited Liability Company received?
FDA Intel has 1 Form 483 on file for Sucampo Pharma Limited Liability Company; the most recent is dated Aug 23, 2019.
When was Sucampo Pharma Limited Liability Company last inspected by FDA?
The most recent FDA inspection document on file for Sucampo Pharma Limited Liability Company is a Form 483 dated Aug 23, 2019, for the site in SANDA, Japan.
What did FDA cite at Sucampo Pharma Limited Liability Company?
The regulations cited most in the observations on file for Sucampo Pharma Limited Liability Company are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.198 (Complaint files), 1 time.