Sucampo Pharma Limited Liability Company
Form 483 issued August 23, 2019 · SANDA, Japan
- Inspection
- Aug 19 – Aug 23, 2019
- Investigator
- Brian D. Nicholson
- Observations
- 4
- Pages
- 2
- FEI number
- 3004520523
In short: On August 23, 2019, FDA issued a Form 483 with 4 observations to Sucampo Pharma Limited Liability Company in SANDA, Hyogo (FEI 3004520523) after an inspection that ran Aug 19 – Aug 23, 2019. The investigator was Brian D. Nicholson. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Your firm does not have validated process parameters for dissolution…
- 03
Complaints regarding lack of effect are not always thoroughly investigated. The following 6 out of 10…
- 04
Your gas chromatography instrument and software uses a shared ‘operator login for all analysts who use…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmSucampo Pharma Limited Liability Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sucampo Pharma Limited Liability Company?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Sucampo Pharma Limited Liability Company?
Brian D. Nicholson is named on this Form 483, for the inspection of Aug 19 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Sucampo Pharma Limited Liability Company inspected by FDA?
The inspection ran Aug 19 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
How do I get the full Form 483 for Sucampo Pharma Limited Liability Company?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.