Pfizer Italia S.r.l.
Form 483 issued June 29, 2018 · Ascoli Piceno, Italy
- Inspection
- Jun 25 – Jun 29, 2018
- Investigator
- Sandra A. Hughes
- Observations
- 4
- Pages
- 2
- FEI number
- 3003637173
In short: On June 29, 2018, FDA issued a Form 483 with 4 observations to Pfizer Italia S.r.l. in Ascoli Piceno, Italy (FEI 3003637173) after an inspection that ran Jun 25 – Jun 29, 2018. The investigator was Sandra A. Hughes. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The procedures designed to assure the drug products produced have the identity, strength, quality and purity…
- 03
The written stability program for Capsules does not include specific test methods in…
- 04
Written procedures are lacking which describe in sufficient detail the sampling…
This inspection in context
Sandra A. Hughes
23 documents · 2009–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
The firmPfizer Italia S.r.l. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Italia S.r.l.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Pfizer Italia S.r.l.?
Sandra A. Hughes is named on this Form 483, for the inspection of Jun 25 – Jun 29, 2018. Each investigator has a profile showing what they cite most.
When was Pfizer Italia S.r.l. inspected by FDA?
The inspection ran Jun 25 – Jun 29, 2018, and the Form 483 is dated June 29, 2018.
How do I get the full Form 483 for Pfizer Italia S.r.l.?
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.