Patheon Italia S.p.A
Form 483 issued September 7, 2016 · Ferentino, Italy
- Inspection
- Aug 29 – Sep 7, 2016
- Investigators
- Marion Michaelis· Wayne Seifert
- Observations
- 7
- Pages
- 3
- FEI number
- 3004110157
In short: On September 7, 2016, FDA issued a Form 483 with 7 observations to Patheon Italia S.p.A in Ferentino, Italy (FEI 3004110157) after an inspection that ran Aug 29 – Sep 7, 2016. The investigators were Marion Michaelis and Wayne Seifert. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm failed to…
- 02
On 1 September 2016 during media fill, a vessel with a crimped transfer line was observed…
- 03
There has been no validation performed for the specified ®@ (14) ) clean hold…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Marion Michaelis
5 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Japan.
The firmPatheon Italia S.p.A history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Italia S.p.A?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Patheon Italia S.p.A?
Marion Michaelis and Wayne Seifert are named on this Form 483, for the inspection of Aug 29 – Sep 7, 2016. Each investigator has a profile showing what they cite most.
When was Patheon Italia S.p.A inspected by FDA?
The inspection ran Aug 29 – Sep 7, 2016, and the Form 483 is dated September 7, 2016.
How do I get the full Form 483 for Patheon Italia S.p.A?
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.