Corden Pharma SPA
Form 483 issued July 15, 2016 · Caponago, Italy
- Inspection
- Jul 7 – Jul 15, 2016
- Investigators
- Linda F. Murphy· Xiaoping Guan
- Observations
- 8
- Pages
- 6
- FEI number
- 3002880938
In short: On July 15, 2016, FDA issued a Form 483 with 8 observations to Corden Pharma SPA in Caponago, Italy (FEI 3002880938) after an inspection that ran Jul 7 – Jul 15, 2016. The investigators were Linda F. Murphy and Xiaoping Guan. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
5 of 8 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do…
- 04
Adequate lab facilities for testing and approval or rejection of components, in-process materials and drug products…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corden Pharma SPA?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Corden Pharma SPA?
Linda F. Murphy and Xiaoping Guan are named on this Form 483, for the inspection of Jul 7 – Jul 15, 2016. Each investigator has a profile showing what they cite most.
When was Corden Pharma SPA inspected by FDA?
The inspection ran Jul 7 – Jul 15, 2016, and the Form 483 is dated July 15, 2016.
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.