Corden Pharma SPA
Form 483 issued July 10, 2018 · Caponago, Italy
- Inspection
- Jul 2 – Jul 10, 2018
- Investigator
- Christopher Keating
- Observations
- 6
- Pages
- 2
- FEI number
- 3002880938
In short: On July 10, 2018, FDA issued a Form 483 with 6 observations to Corden Pharma SPA in Caponago, Italy (FEI 3002880938) after an inspection that ran Jul 2 – Jul 10, 2018. The investigator was Christopher Keating. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Records of inspections of automatic, mechanical, or electronic equipment, including computers or related…
- 03
Established specifications are not…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCorden Pharma SPA history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corden Pharma SPA?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Corden Pharma SPA?
Christopher Keating is named on this Form 483, for the inspection of Jul 2 – Jul 10, 2018. Each investigator has a profile showing what they cite most.
When was Corden Pharma SPA inspected by FDA?
The inspection ran Jul 2 – Jul 10, 2018, and the Form 483 is dated July 10, 2018.
How do I get the full Form 483 for Corden Pharma SPA?
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.