Corden Pharma Bergamo SpA
Form 483 issued September 27, 2018 · Treviglio, Italy
- Observations
- 7
- Pages
- 2
- FEI number
- 3002806963
In short: On September 27, 2018, FDA issued a Form 483 with 7 observations to Corden Pharma Bergamo SpA in Treviglio, Italy (FEI 3002806963). Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and production account for 5 of 7 observations.
Most cited: 21 CFR 211.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm retested out of specification drug samples obtaining new reportable results and invalidated the original…
- 02
Investigations do not always include a corrective and preventative action (CAPA) to prevent…
- 03
Complaint investigation 1014 is incomplete and does not include a trending of similar complaints in the…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Questions about this 483
What did FDA find at Corden Pharma Bergamo SpA?
FDA listed 7 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
When was Corden Pharma Bergamo SpA inspected by FDA?
This Form 483 is dated September 27, 2018.
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.