Corden Pharma Bergamo SpA
Form 483 issued June 17, 2016 · Treviglio, Italy
- Inspection
- Jun 13 – Jun 17, 2016
- Observations
- 4
- Pages
- 4
- FEI number
- 3002806963
In short: On June 17, 2016, FDA issued a Form 483 with 4 observations to Corden Pharma Bergamo SpA in Treviglio, Italy (FEI 3002806963) after an inspection that ran Jun 13 – Jun 17, 2016. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials 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
Each drug component is not tested for conformity with all appropriate written specifications for…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
Appropriate controls are not exercised over laboratory…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
This inspection in context
Questions about this 483
What did FDA find at Corden Pharma Bergamo SpA?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and production. The opening words of each observation are shown on this page.
When was Corden Pharma Bergamo SpA inspected by FDA?
The inspection ran Jun 13 – Jun 17, 2016, and the Form 483 is dated June 17, 2016.
How do I get the full Form 483 for Corden Pharma Bergamo 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.